| |
Class 2 Device Recall GE Centricity PACSIW |
 |
| Date Initiated by Firm |
May 22, 2019 |
| Create Date |
June 13, 2019 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1781-2019 |
| Recall Event ID |
83002 |
| 510(K)Number |
K082318
|
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product |
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers:
a) 2052831-00x
b) 2050578-0xx
c) 2090228-002
d) 2052782-00x
|
| Code Information |
a) 2052831-00x, Lot or Serial Numbers: 100839-1-Centricity PACS-IW-00558122 100893-1-Centricity PACS-IW-00558171 4320-1-Centricity PACS-IW-00558202 4474-1-Centricity PACS-IW-00558169 2455-1-Centricity PACS-IW-00558139 100863-1-Centricity PACS-IW-00558143 100794-1-Centricity PACS-IW-00558193 4346-1-Centricity PACS-IW-00558136 100909-1-Centricity PACS-IW-00558198 4355-1-Centricity PACS-IW-00558204 100809-1-Centricity PACS-IW-00558124 4300-1-Centricity PACS-IW-00558207 4484-1-Centricity PACS-IW-00558213 4479-1-Centricity PACS-IW-00558214 13240-2-Centricity PACS-IW-01225875 4270-1-Centricity PACS-IW-00558129 11059-2-Centricity PACS-IW-00558101 101598-1-Centricity PACS-IW-00667133 4273-1-Centricity PACS-IW-01225873 4357-1-Centricity PACS-IW-00558444 4293-1-Centricity PACS-IW-00558131 100835-1-Centricity PACS-IW-00558568 100900-1-Centricity PACS-IW-00558170 4344-1-Centricity PACS-IW-00558196 3836-1-Centricity PACS-IW-00558179 4428-1-Centricity PACS-IW-00558205 100609-1-Centricity PACS-IW-00558130 4297-1-Centricity PACS-IW-00558134 100975-1-Centricity PACS-IW-00558137 100667-1-Centricity PACS-IW-00558163 4316-1-Centricity PACS-IW-00558210 4251-1-Centricity PACS-IW-00558120 4254-1-Centricity PACS-IW-00558211 100981-1-Centricity PACS-IW-00558132 100871-1-Centricity PACS-IW-00558146 2553-1-Centricity PACS-IW-00558206 4283-1-Centricity PACS-IW-00558187 4469-1-Centricity PACS-IW-00558128 100020-1-Centricity PACS-IW-00558147 4443-1-Centricity PACS-IW-00558167 4317-1-Centricity PACS-IW-00558208 100775-1-Centricity PACS-IW-00558209 4323-1-Centricity PACS-IW-00558164 100825-1-Centricity PACS-IW-00558172 100830-1-Centricity PACS-IW-00558166 4304-1-Centricity PACS-IW-00558145 4721-1-Centricity PACS-IW-00558138 4104-1-Centricity PACS-IW-00558133 4292-1-Centricity PACS-IW-00558203 100980-1-Centricity PACS-IW-00558140 4343-1-Centricity PACS-IW-00558115 4298-1-Centricity PACS-IW-00558116 4252-1-Centricity PACS-IW-00558119 4287-1-Centricity PACS-IW-00558117 4291-1-Centricity PACS-IW-00558194 100978-1-Centricity PACS-IW-00558141 4448-1-Centricity PACS-IW-00558118 100979-1-Centricity PACS-IW-00558142 100865-1-Centricity PACS-IW-01225871 100807-1-Centricity PACS-IW-00558121 100807-1-Centricity PACS-IW-00558212 4424-1-Centricity PACS-IW-00558429 339142-Centricity PACS-IW-01431503 13759-Centricity PACS-IW-01431508 320090-Centricity PACS-IW-01444604 320092-Centricity PACS-IW-01444618 297958-Centricity PACS-IW-01444903 329997-Centricity PACS-IW-01444898 AiKang-Centricity PACS-IW-01824737 SiteID-Centricity PACS-IW-01572187 SiteID-Centricity PACS-IW-01797297 339734-Centricity PACS-IW-01444878 313825-Centricity PACS-IW-01444348 332562-Centricity PACS-IW-01444345 338295-Centricity PACS-IW-01443383 SiteID-Centricity PACS-IW-01444354 SiteID-Centricity PACS-IW-02003770 276233-Centricity PACS-IW-01444355 331973-Centricity PACS-IW-01434505 279961-Centricity PACS-IW-01444358 SiteID-Centricity PACS-IW-00161903 SiteID-Centricity PACS-IW-00161906 186588-Centricity PACS-IW-01461366 SiteID-Centricity PACS-IW-02095351 RU9038-Centricity PACS-IW-01273313 RU1107-Centricity PACS-IW-01273202 MPX431-Centricity PACS-IW-00044783 b) 2050578-0xx Lot or Serial Numbers: 100664-1-Centricity PACS-IW-00558437 100639-1-Centricity PACS-IW-00558450 4261-1-Centricity PACS-IW-00558480 101587-1-Centricity PACS-IW-00558369 4614-1-Centricity PACS-IW-00558393 4376-1-Centricity PACS-IW-00558399 4436-1-Centricity PACS-IW-00558417 4350-13-Centricity PACS-IW-00558296 4680-1-Centricity PACS-IW-00558360 100666-1-Centricity PACS-IW-00558465 101171-1-Centricity PACS-IW-00558310 101792-1-Centricity PACS-IW-00558370 4264-1-Centricity PACS-IW-00558254 4286-1-Centricity PACS-IW-00558361 4284-1-Centricity PACS-IW-00558453 4605-1-Centricity PACS-IW-00558350 4446-2-Centricity PACS-IW-00558106 4280-1-Centricity PACS-IW-00558240 12830-1-Centricity PACS-IW-00558312 100580-1-Centricity PACS-IW-00558339 100858-1-Centricity PACS-IW-00558426 100674-1-Centricity PACS-IW-00558315 102206-1-Centricity PACS-IW-00558447 4684-1-Centricity PACS-IW-00558245 4256-1-Centricity PACS-IW-00558250 4707-1-Centricity PACS-IW-00558434 100783-1-Centricity PACS-IW-00558255 4263-1-Centricity PACS-IW-00558279 100970-1-Centricity PACS-IW-00558303 4689-1-Centricity PACS-IW-00558242 100767-1-Centricity PACS-IW-00558377 100766-1-Centricity PACS-IW-00558355 100764-1-Centricity PACS-IW-00558452 100765-1-Centricity PACS-IW-00558331 4350-1-Centricity PACS-IW-00558301 4350-1-Centricity PACS-IW-00558307 4350-1-Centricity PACS-IW-00558318 4350-1-Centricity PACS-IW-00558432 4109-1-Centricity PACS-IW-00558389 4485-1-Centricity PACS-IW-00558479 100485-1-Centricity PACS-IW-00558258 100759-1-Centricity PACS-IW-00558268 4687-1-Centricity PACS-IW-00558334 1005-1-Centricity PACS-IW-00558282 1005-1-Centricity PACS-IW-00558290 100836-1-Centricity PACS-IW-00558256 4311-1-Centricity PACS-IW-00558321 100757-1-Centricity PACS-IW-00558261 4679-1-Centricity PACS-IW-00558412 100718-1-Centricity PACS-IW-00558424 13332-1-Centricity PACS-IW-00558390 4294-1-Centricity PACS-IW-00558379 13360-1-Centricity PACS-IW-00558263 12908-1-Centricity PACS-IW-00558302 4359-1-Centricity PACS-IW-00558410 13039-1-Centricity PACS-IW-00558385 100166-1-Centricity PACS-IW-00558448 9757-1-Centricity PACS-IW-00558247 1412-1-Centricity PACS-IW-00558228 4274-1-Centricity PACS-IW-00558436 100156-1-Centricity PACS-IW-00558243 100156-1-Centricity PACS-IW-00558475 4723-1-Centricity PACS-IW-00558367 4539-1-Centricity PACS-IW-00558378 101042-1-Centricity PACS-IW-00558386 3189-1-Centricity PACS-IW-00558314 4495-1-Centricity PACS-IW-00558476 4734-1-Centricity PACS-IW-00558375 100701-1-Centricity PACS-IW-00558322 100722-1-Centricity PACS-IW-00558407 2035-1-Centricity PACS-IW-00558411 101742-1-Centricity PACS-IW-00558470 104648-2-Centricity PACS-IW-00558406 4670-1-Centricity PACS-IW-00558329 100855-1-Centricity PACS-IW-00558298 4385-1-Centricity PACS-IW-00558336 4260-1-Centricity PACS-IW-00558244 100065-1-Centricity PACS-IW-00558317 4295-1-Centricity PACS-IW-00558341 13209-1-Centricity PACS-IW-00558357 4676-1-Centricity PACS-IW-00558449 13295-1-Centricity PACS-IW-00558346 9791-1-Centricity PACS-IW-00558418 4273-1-Centricity PACS-IW-01225873 4269-1-Centricity PACS-IW-00558252 100589-1-Centricity PACS-IW-00558384 13337-1-Centricity PACS-IW-00558401 13337-1-Centricity PACS-IW-00558478 100876-1-Centricity PACS-IW-00558440 11764-1-Centricity PACS-IW-00558388 101689-1-Centricity PACS-IW-00558326 9764-1-Centricity PACS-IW-00558394 100835-1-Centricity PACS-IW-00558287 100831-1-Centricity PACS-IW-00558232 4744-1-Centricity PACS-IW-00558373 100772-1-Centricity PACS-IW-00558269 4281-1-Centricity PACS-IW-00558354 12960-1-Centricity PACS-IW-00558289 9978-3-Centricity PACS-IW-00558108 1402-1-Centricity PACS-IW-00558291 4321-1-Centricity PACS-IW-00558371 4381-1-Centricity PACS-IW-00558423 1451-1-Centricity PACS-IW-00558294 13175-1-Centricity PACS-IW-00558383 10467-1-Centricity PACS-IW-00558405 10911-1-Centricity PACS-IW-00558471 100821-1-Centricity PACS-IW-00558325 4425-1-Centricity PACS-IW-00558472 4268-1-Centricity PACS-IW-00558416 9844-1-Centricity PACS-IW-00558332 9767-1-Centricity PACS-IW-00558265 4305-1-Centricity PACS-IW-00558337 4367-1-Centricity PACS-IW-00558415 4128-1-Centricity PACS-IW-00558234 101098-1-Centricity PACS-IW-00558387 4322-1-Centricity PACS-IW-00558285 4352-1-Centricity PACS-IW-00558316 4374-1-Centricity PACS-IW-00558422 100827-1-Centricity PACS-IW-00558233 4360-1-Centricity PACS-IW-00558237 4335-1-Centricity PACS-IW-00558267 4349-1-Centricity PACS-IW-00558284 4211-1-Centricity PACS-IW-00558277 3545-1-Centricity PACS-IW-00558239 10527-3-Centricity PACS-IW-00558344 4348-1-Centricity PACS-IW-00558458 4362-1-Centricity PACS-IW-00558395 4576-1-Centricity PACS-IW-00558306 10916-1-Centricity PACS-IW-00558299 4288-1-Centricity PACS-IW-00558235 4266-1-Centricity PACS-IW-00558304 100511-1-Centricity PACS-IW-00558549 1565-1-Centricity PACS-IW-00603058 4277-1-Centricity PACS-IW-00558474 4553-1-Centricity PACS-IW-00558327 101216-1-Centricity PACS-IW-00558356 4531-1-Centricity PACS-IW-00558376 101240-1-Centricity PACS-IW-00558425 100021-1-Centricity PACS-IW-00558260 4660-1-Centricity PACS-IW-00558288 2481-1-Centricity PACS-IW-00558381 4447-1-Centricity PACS-IW-00558398 4078-1-Centricity PACS-IW-00558462 100806-1-Centricity PACS-IW-00558441 4361-1-Centricity PACS-IW-00558343 13164-1-Centricity PACS-IW-00558439 4504-1-Centricity PACS-IW-00558438 4413-1-Centricity PACS-IW-00558433 4416-1-Centricity PACS-IW-00558292 4416-1-Centricity PACS-IW-00558293 4417-1-Centricity PACS-IW-00558364 4419-1-Centricity PACS-IW-00558483 4420-1-Centricity PACS-IW-00558404 100378-1-Centricity PACS-IW-00558238 4508-1-Centricity PACS-IW-00558271 100603-1-Centricity PACS-IW-00558266 10462-1-Centricity PACS-IW-00558272 12953-1-Centricity PACS-IW-00558443 10483-1-Centricity PACS-IW-00558098 1331-1-Centricity PACS-IW-00558451 12949-1-Centricity PACS-IW-00558442 4296-1-Centricity PACS-IW-00558477 100088-1-Centricity PACS-IW-00558320 4351-1-Centricity PACS-IW-00558485 1584-1-Centricity PACS-IW-00558297 1173-1-Centricity PACS-IW-00558473 4450-1-Centricity PACS-IW-00558319 100972-1-Centricity PACS-IW-00558278 4276-1-Centricity PACS-IW-00558274 101647-1-Centricity PACS-IW-00558515 11711-2-Centricity PACS-IW-00558262 4542-1-Centricity PACS-IW-00558430 13265-1-Centricity PACS-IW-00558482 12974-1-Centricity PACS-IW-00558300 100770-1-Centricity PACS-IW-00558097 100769-1-Centricity PACS-IW-00558427 4393-1-Centricity PACS-IW-00558328 13372-1-Centricity PACS-IW-00558309 13197-1-Centricity PACS-IW-00558251 11042-1-Centricity PACS-IW-00558368 100468-1-Centricity PACS-IW-00558330 4575-1-Centricity PACS-IW-00558342 12931-1-Centricity PACS-IW-00558419 4482-1-Centricity PACS-IW-00558281 4568-1-Centricity PACS-IW-00558280 3571-1-Centricity PACS-IW-00558468 100645-1-Centricity PACS-IW-00558408 100771-1-Centricity PACS-IW-00558249 4632-1-Centricity PACS-IW-00558311 4681-1-Centricity PACS-IW-00558431 4573-1-Centricity PACS-IW-00558420 100729-1-Centricity PACS-IW-00558455 4456-1-Centricity PACS-IW-00558295 4506-1-Centricity PACS-IW-00558345 BA4080-Centricity PACS-IW-00038769 324462-Centricity PACS-IW-01431554 293035-Centricity PACS-IW-01401532 280801-Centricity PACS-IW-01431490 335279-Centricity PACS-IW-01431638 306930-Centricity PACS-IW-01401530 296619-Centricity PACS-IW-01401506 330917-Centricity PACS-IW-01401529 SiteID-Centricity PACS-IW-01422991 313741-Centricity PACS-IW-01422998 238110-Centricity PACS-IW-01431521 246838-Centricity PACS-IW-01421153 134265-Centricity PACS-IW-01431539 307319-Centricity PACS-IW-01444609 230048-Centricity PACS-IW-01442018 SiteID-Centricity PACS-IW-01444879 209545-Centricity PACS-IW-01460552 EG1856-Centricity PACS-IW-00118541 EG1009-Centricity PACS-IW-00118535 EG1871-Centricity PACS-IW-00118532 EG1905-Centricity PACS-IW-00117725 EG1771-Centricity PACS-IW-00118550 EG1858-Centricity PACS-IW-00118544 EG1808-Centricity PACS-IW-00118538 EG1857-Centricity PACS-IW-00118547 M41678-Centricity PACS-IW-00043697 M41741-Centricity PACS-IW-00043705 M42172-Centricity PACS-IW-00165182 683198-Centricity PACS-IW-00000826 600791-Centricity PACS-IW-00000776 UHAM02-Centricity PACS-IW-00001927 RMUE01-Centricity PACS-IW-00001801 PC0125-Centricity PACS-IW-00001683 HU1025-Centricity PACS-IW-00038776 HU1469-Centricity PACS-IW-00038785 HU1038-Centricity PACS-IW-00038778 HU1093-Centricity PACS-IW-00038784 HU1397-Centricity PACS-IW-00038782 HU1185-Centricity PACS-IW-00038781 HU1433-Centricity PACS-IW-00038783 HU1008-Centricity PACS-IW-00038775 HU1036-Centricity PACS-IW-00038777 HU1041-Centricity PACS-IW-00038780 HU1039-Centricity PACS-IW-00038779 ApolloBSR-Centricity PACS-IW-01819452 StThomas-Centricity PACS-IW-01819447 HOLY-FAMILY-THODU-Centricity PACS-IW-01821493 SODANI-Centricity PACS-IW-01819445 WOCKHARDT-Centricity PACS-IW-01819449 DAKE-Centricity PACS-IW-01819448 SIMS-Centricity PACS-IW-01819453 MARTHANDAM-Centricity PACS-IW-01819446 CTSI-Centricity PACS-IW-01819444 CONTINENTAL-Centricity PACS-IW-01819443 197240-Centricity PACS-IW-01442043 KW1112-Centricity PACS-IW-00168151 LB1331-Centricity PACS-IW-00116959 REGENCY-Centricity PACS-IW-01286180 BEVERLY-Centricity PACS-IW-01288659 MAHKOTA-Centricity PACS-IW-01286179 UMUM-Centricity PACS-IW-01288666 5791-Centricity PACS-IW-01442181 324271-Centricity PACS-IW-01970711 AMS39-Centricity PACS-IW-00044104 PL1731-Centricity PACS-IW-00038835 PL1517-Centricity PACS-IW-00038837 PL1515-Centricity PACS-IW-00038839 PL1394-Centricity PACS-IW-00038841 PL1639-Centricity PACS-IW-00038843 PL1426-Centricity PACS-IW-00038845 PL1491-Centricity PACS-IW-00038847 PL2619-Centricity PACS-IW-00038814 PL1631-Centricity PACS-IW-00038849 PL1684-Centricity PACS-IW-00038851 PL1942-Centricity PACS-IW-00038853 PL1825-Centricity PACS-IW-00038819 PL1505-Centricity PACS-IW-00038855 PL3249-Centricity PACS-IW-00038865 PL3249-Centricity PACS-IW-00038868 PL3249-Centricity PACS-IW-00038870 PL3249-Centricity PACS-IW-00038871 PL1530-Centricity PACS-IW-00038822 PL2762-Centricity PACS-IW-00038828 PL1544-Centricity PACS-IW-00038859 PL1644-Centricity PACS-IW-00038861 PL1650-Centricity PACS-IW-00038857 PL1508-Centricity PACS-IW-00038863 QA1015-Centricity PACS-IW-00115165 RU3382-Centricity PACS-IW-01273247 RU3680-Centricity PACS-IW-01273260 RU3380-Centricity PACS-IW-01273246 SA2187-Centricity PACS-IW-00065875 SA2294-Centricity PACS-IW-00065843 SA1198-Centricity PACS-IW-00065868 SA1175-Centricity PACS-IW-00038187 SiteID-Centricity PACS-IW-02266272 MPX352-Centricity PACS-IW-01973993 DP7603-Centricity PACS-IW-00045307 UP506-Centricity PACS-IW-00044759 529010-Centricity PACS-IW-00000342 ONCOLOGY-Centricity PACS-IW-01288658 115-Centricity PACS-IW-01288657 c) 2090228-002 Lot or Serial Numbers: 3640-1-Centricity PACS-IW-00558511 4345-1-Centricity PACS-IW-00558548 4430-1-Centricity PACS-IW-00558500 4378-1-Centricity PACS-IW-00558498 100663-1-Centricity PACS-IW-00558514 100674-1-Centricity PACS-IW-00558486 9754-1-Centricity PACS-IW-00558490 4429-1-Centricity PACS-IW-00558499 4328-1-Centricity PACS-IW-00558518 4552-1-Centricity PACS-IW-00558510 4387-1-Centricity PACS-IW-00558493 100702-1-Centricity PACS-IW-00558539 100717-1-Centricity PACS-IW-00558517 101625-1-Centricity PACS-IW-00558531 4593-1-Centricity PACS-IW-00558488 100009-1-Centricity PACS-IW-00558560 4354-1-Centricity PACS-IW-00558519 100838-1-Centricity PACS-IW-00558532 4551-1-Centricity PACS-IW-00558508 100199-1-Centricity PACS-IW-00558503 12968-1-Centricity PACS-IW-00558506 13102-1-Centricity PACS-IW-00558512 4379-1-Centricity PACS-IW-00558496 4366-1-Centricity PACS-IW-00558542 4694-1-Centricity PACS-IW-00558556 1635-1-Centricity PACS-IW-00558557 100881-1-Centricity PACS-IW-00558546 4299-2-Centricity PACS-IW-00558545 10884-2-Centricity PACS-IW-00558100 101883-1-Centricity PACS-IW-00558487 100852-1-Centricity PACS-IW-00558494 4368-1-Centricity PACS-IW-00558513 4668-1-Centricity PACS-IW-00558529 100811-1-Centricity PACS-IW-00558535 4497-1-Centricity PACS-IW-00558497 4682-1-Centricity PACS-IW-00558270 100458-1-Centricity PACS-IW-00558538 4358-1-Centricity PACS-IW-00558564 13095-1-Centricity PACS-IW-00558534 13064-2-Centricity PACS-IW-00558102 4372-1-Centricity PACS-IW-00558523 4326-4-Centricity PACS-IW-00558105 101932-1-Centricity PACS-IW-00558495 4301-1-Centricity PACS-IW-00558525 10750-1-Centricity PACS-IW-00558536 100761-1-Centricity PACS-IW-00558527 10749-1-Centricity PACS-IW-00558509 2387-1-Centricity PACS-IW-00558489 10250-1-Centricity PACS-IW-00558504 100802-1-Centricity PACS-IW-00558540 101193-1-Centricity PACS-IW-00558551 1475-1-Centricity PACS-IW-00558558 12821-1-Centricity PACS-IW-00558526 4661-1-Centricity PACS-IW-00558528 2481-1-Centricity PACS-IW-00558524 3943-1-Centricity PACS-IW-00558501 4299-2-Centricity PACS-IW-02180909 13134-1-Centricity PACS-IW-00558492 4157-1-Centricity PACS-IW-00558516 4383-1-Centricity PACS-IW-00558533 13233-1-Centricity PACS-IW-00558554 4389-1-Centricity PACS-IW-00558563 100582-1-Centricity PACS-IW-00558530 4179-1-Centricity PACS-IW-00558543 DZ1004-Centricity PACS-IW-00116835 BH1038-Centricity PACS-IW-00162931 80083-Centricity PACS-IW-00043981 SiteID-Centricity PACS-IW-01431505 332921-Centricity PACS-IW-01442042 313689-Centricity PACS-IW-01431524 SiteID-Centricity PACS-IW-01401523 000341097-Centricity PACS-IW-01431636 191244-Centricity PACS-IW-01422989 298983-Centricity PACS-IW-01401548 293834-Centricity PACS-IW-01422975 302144-Centricity PACS-IW-01421157 32125-Centricity PACS-IW-01444621 13628-Centricity PACS-IW-01422992 213537-Centricity PACS-IW-01431510 000282202-Centricity PACS-IW-01422973 319674-Centricity PACS-IW-01431535 369946-Centricity PACS-IW-01264977 218314-Centricity PACS-IW-01434509 248553-Centricity PACS-IW-01442041 EG1017-Centricity PACS-IW-00117723 X2575258-Centricity PACS-IW-00043952 M43994-Centricity PACS-IW-00043773 M60364-Centricity PACS-IW-00043899 X1413896-Centricity PACS-IW-00043945 TESTSITE-Centricity PACS-IW-01986381 714235-Centricity PACS-IW-00000842 972439-Centricity PACS-IW-00000859 363691-Centricity PACS-IW-00000520 424881-Centricity PACS-IW-00000556 A2513980-Centricity PACS-IW-00040355 A56306-Centricity PACS-IW-00040439 PUSANPAIK-Centricity PACS-IW-01819440 CHILGOK-Centricity PACS-IW-01819441 KANGBUK-Centricity PACS-IW-01819442 1971565-YUHSSC-RAD-Centricity PACS-IW-01819454 KW1003-Centricity PACS-IW-01798078 KW1019-Centricity PACS-IW-00115173 KW1018-Centricity PACS-IW-01422962 KW1001-Centricity PACS-IW-00164288 KW1096-Centricity PACS-IW-00166324 SSH-Centricity PACS-IW-01288660 NG1043-IW w UW Base SW PVP-00158638 MYHEALTH-Centricity PACS-IW-01819534 StLukes-Centricity PACS-IW-01286216 PL2059-Centricity PACS-IW-00038789 PL2997-Centricity PACS-IW-00038793 PL1803-Centricity PACS-IW-00038812 PL2823-Centricity PACS-IW-00038813 PL2342-Centricity PACS-IW-00038815 PL1666-Centricity PACS-IW-00038816 PL2257-Centricity PACS-IW-00038817 PL1961-Centricity PACS-IW-00038818 PL3092-Centricity PACS-IW-00038830 PL1006-Centricity PACS-IW-00038821 PL1822-Centricity PACS-IW-00038825 PL3362-Centricity PACS-IW-00038833 PL1951-Centricity PACS-IW-00038827 RU1016-Centricity PACS-IW-01273193 RU1241-Centricity PACS-IW-01273216 RU1493-Centricity PACS-IW-01273220 RU2967-Centricity PACS-IW-01273244 RU5302-Centricity PACS-IW-01273274 RU2420-Centricity PACS-IW-01273234 RU3910-Centricity PACS-IW-01273270 RU3262-Centricity PACS-IW-01273245 RU6248-Centricity PACS-IW-01273279 RU1648-Centricity PACS-IW-01273222 RU8071-Centricity PACS-IW-01273295 RU6340-Centricity PACS-IW-01273280 RU6340-Centricity PACS-IW-01273282 RU7576-Centricity PACS-IW-01273287 RU3880-Centricity PACS-IW-01273266 RU3894-Centricity PACS-IW-01273269 RU3564-Centricity PACS-IW-01273252 RU8162-Centricity PACS-IW-01273299 RU2527-Centricity PACS-IW-01273235 RU5310-Centricity PACS-IW-01273276 RU3959-Centricity PACS-IW-01273273 RU2878-Centricity PACS-IW-01273243 RU8370-Centricity PACS-IW-01273306 RU3572-Centricity PACS-IW-01273255 600160-Centricity PACS-IW-01273191 RU3625-Centricity PACS-IW-01273258 RU5499-Centricity PACS-IW-01273278 RU1469-Centricity PACS-IW-01273219 RU1199-Centricity PACS-IW-01273215 RU1717-Centricity PACS-IW-01273225 RU9000-Centricity PACS-IW-01273312 RU8041-Centricity PACS-IW-01273294 RU1857-Centricity PACS-IW-01273229 RU8219-Centricity PACS-IW-01273302 RU1279-Centricity PACS-IW-01273217 RU1095-Centricity PACS-IW-01273200 RU7000-Centricity PACS-IW-01273281 RU8321-Centricity PACS-IW-01273303 RU7563-Centricity PACS-IW-01273285 RU1130-Centricity PACS-IW-01273210 RU2371-Centricity PACS-IW-01273233 RU7426-Centricity PACS-IW-01273284 RU2167-Centricity PACS-IW-01273231 RU3890-Centricity PACS-IW-01273268 RU3828-Centricity PACS-IW-01273262 RU1669-Centricity PACS-IW-01273224 RU5308-Centricity PACS-IW-01273275 RU8953-Centricity PACS-IW-01273311 RU2367-Centricity PACS-IW-01273232 RU1026-Centricity PACS-IW-01273195 RU3476-Centricity PACS-IW-01273251 RU1050-Centricity PACS-IW-01273198 RU1050-Centricity PACS-IW-00167296 RU7564-Centricity PACS-IW-01273286 RU8036-Centricity PACS-IW-01273293 RU3570-Centricity PACS-IW-01273254 RU3610-Centricity PACS-IW-01273257 RU3794-Centricity PACS-IW-01273261 RU8192-Centricity PACS-IW-01273300 RU8192-Centricity PACS-IW-01273301 RU3832-Centricity PACS-IW-01273263 RU1144-Centricity PACS-IW-01273211 600100-Centricity PACS-IW-01273188 RU3878-Centricity PACS-IW-01273265 RU1028-Centricity PACS-IW-01273197 RU3925-Centricity PACS-IW-01273272 RU1055-Centricity PACS-IW-01273199 RU3919-Centricity PACS-IW-01273271 RU1022-Centricity PACS-IW-01273194 RU5442-Centricity PACS-IW-01273277 RU3883-Centricity PACS-IW-01273267 RU3467-Centricity PACS-IW-01273250 RU3663-Centricity PACS-IW-01273259 RU7905-Centricity PACS-IW-01273291 RU3593-Centricity PACS-IW-01273256 RU1298-Centricity PACS-IW-01273218 RU8151-Centricity PACS-IW-01273296 RU7838-Centricity PACS-IW-01273289 RU7838-Centricity PACS-IW-01273290 RU1152-Centricity PACS-IW-01273212 RU8607-Centricity PACS-IW-01273308 RU3569-Centricity PACS-IW-01273253 SA2128-Centricity PACS-IW-00065800 SA1126-Centricity PACS-IW-00065887 SA2235-Centricity PACS-IW-00038164 SA2221-Centricity PACS-IW-00065837 ZA2408-Centricity PACS-IW-00116590 ZA2339-Centricity PACS-IW-00116589 ZA2356-Centricity PACS-IW-00116576 ZA2355-Centricity PACS-IW-00116575 ZA2338-Centricity PACS-IW-00116588 ZA2331-Centricity PACS-IW-00116443 ZA2335-Centricity PACS-IW-00116447 ZA2330-Centricity PACS-IW-00116442 ZA2334-Centricity PACS-IW-00116446 ZA2409-Centricity PACS-IW-00116591 ZA2410-Centricity PACS-IW-00116592 ZA2336-Centricity PACS-IW-00116448 ZA2470-Centricity PACS-IW-00116572 ZA2352-Centricity PACS-IW-00116570 ZA2351-Centricity PACS-IW-00116569 ZA2474-Centricity PACS-IW-00116763 ZA2471-Centricity PACS-IW-00116573 YP5673-Centricity PACS-IW-00045220 941804-Centricity PACS-IW-00000474 d) 2052782-00x Lot or Serial Numbers: 100884-1-Centricity PACS-IW-00558222 100832-1-Centricity PACS-IW-00558224 100828-1-Centricity PACS-IW-00558231 100954-1-Centricity PACS-IW-00558225 100826-1-Centricity PACS-IW-00558229 4595-1-Centricity PACS-IW-00558226 4290-1-Centricity PACS-IW-00558217 4364-1-Centricity PACS-IW-00558219 4524-1-Centricity PACS-IW-00558218 4536-1-Centricity PACS-IW-00558216 |
Recalling Firm/
Manufacturer |
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
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| For Additional Information Contact |
800-437-1171
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Manufacturer Reason
for Recall |
There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
|
FDA Determined
Cause 2 |
Software design |
| Action |
The firm initiated their medical device correction by letter on 05/2/2019. The letter explained the problem and the safety issue and provided the following safety instructions:
1) Process Root Causes: Investigation determined that the original PACS-IW foundation design did not incorporate adequate risk mitigation for this part of the image ingestion process. DFMEA of the image ingestion wing to wing process was completed as part of the investigation, and no additional areas where further mitigations are required were identified.
a) If a discrepancy is identified, attempt to retransmit the exam to PACS.
b) If retransmission is unsuccessful, contact a GE Healthcare Service representative for assistance in resolving the impacted exam.
c) Urgent cases impacted by this issue should be interpreted by the clinician at the modality.
2) Be aware that if DICOM storage commit is configured and in use, the modality will not be sent a commit notification for images impacted by this issue.
3) Attention should be given to prior cases, acquired before the application of the safety instructions given in this communication, because they may be affected by this issue. For historical data inquiries, please contact a GE Healthcare service representative for assistance in identifying any affected images.
The units will be upgraded. |
| Quantity in Commerce |
620 units |
| Distribution |
Worldwide |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS
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