Class 2 Device Recall BrightView

• Date Initiated by Firm: November 30, 2023
• Date Posted: January 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0677-2024
• Recall Event ID: 93643
• 510(K)Number: K062298
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: BrightView, Gamma Camera System, Product Code 882480.
• Code Information: No UDI Serial numbers 4000002 4000262 4000681 4000218 4000413 4000312 4000389 4000678 4000484 4000288 4000393 4000393 4000494 4000354 4000699 4000515 4000679 4000479 4000689 4000082 4000373 4000471 4000545 4000331 4000038 4000002 4000060 4000161 4000164 4000360 4000175 4000244 4000186 4000242 4000235 4000255 4000247 4000320 4000347 4000367 4000402 4000430 4000473 4000591 4000537 4000505 4000529 4000524 4000562 4000582 4000606 4000583 4000584 4000662 4000674 4000696 4000282 4000449 7135_11 4000410 4000651 4000652 4000665 4000688 4000350 4000044 4000061 4000081 4000065 4000002.75 4000180 4000224 4000321 4000229 4000280 4000378 4000559 4000552 4000298 4000009 4000190 4000184 4000305 4000303 4000324 4000411 4000516 4000554 4000566 4000576 4000614 4000612 4000627 4000669 4000033 4000070 4000091 4000123 4000102 4000008 4000202 4000166 4000276 4000287 4000364 4000455 4000498 4000497 4000012 4000213 4000197 4000353 4000335 4000418 4000510 4000436 4000454 4000469 4000500 4000491 4000518 4000472A 4000544 4000555 4000592 4000581 4000571 4000617 4000648 4000042 4000005 4000379 4000451 4000533 4000602 4000032 4000029 4000039 4000056 4000051 4000068 4000067 4000045 4000071 4000088 4000006 4000129 4000158 4000003 4000290 4000370 4000283 4000366 4000372 4000328 4000375 4000346 4000336 4000122 4000422 4000417 4000223 4000423 4000301 4000057 4000151 4000197_1 4000487 4000466 4000381 4000536 4000549 4000557 4000550 4000031 4000560 4000567 4000483 4000620 4000607 4000601 4000683 4000343 4000540 4000547 4000316 4000317 4000338 4000408 4000342 4000421 4000511 4000495 4000604 4000664 4000682 458008 4000041 4000030 4000167 4000203 4000407 4000341 4000647 4000125 4000279 4000216 4000269 4000254 4000208 4000345 4000415 4000672 4000286 4000294 4000395 4000390 4340005 4000199 4000281 4000211 4000096 4000348 4000613 4000655 4000419 4000464 4000463 4000462 4000638 4000156 4000049 4000047 4000412 4000268 4000273 4000228 4000382 4000297 4000337 4000169 4000447 4000442 4000488 4000595 4000693 4000692 4000105 4000109 4000107 4000115 4000126 4000121 4000154 4000173 4000179 4000168 4000194 4000227 4000256 4000233 4000257 4000333 4000339 4000356 4000386 4000385 4000401 4000400 4000399 4000397 4000398 4000503 4000504 4000585 4000600 4000631 4000667 4000698 4000072 4000237 4000493 40000699 4000296 4000272 4000478 4000243 4000376 4000416 4000437 4000485 4000219 4000643 4000694 4340004 4000035 4000551 4000691 4000548 4000427 6000046 4000100 4000394 4000459 4000468 4000461 4000210 4000217 4000063 4000150 4000645 4000066 4000142 4000183 4000226 4000475 4000519 4000300 4000420 4000530 4000568 4000572 4000573 4000639 4000640 4000690 4000075 4000080 4000086 4000013 4000396 4000392 4000481 4000157 4000428 4000374 4000621 4000539 4000663 4000153 4000163 4000465 4000134 1406-37 4000409 4000618 4000637 4000641 4000133 4000010 4000209 4000299 4000314 4000477 4000676 4000675 4000686 4000055 4000034 4000040 4000037 4000098A 4000036 4000074 4000046 4000064 4000059 4000050 4000094 4000052 4000048 4000053 40007050005 4000077 4000090 40000101 4000073 4000054 4000087 4000078 4000076 4000095 4000703001 40007060008 4000062 4000089 4000099 4000004 4000083 4000058 4000093 4000149 4000079 4000111 4000117 4000120 4000119 4000110 4000358 4000116 4000196 4000108 4000185 4000103 40000092 4000140 4000241 4000104 4000127 4000136 4000112 4000145 4000189 4000266 4000124 4000234 4000118 4000007 4000113 4000128 4000135 4000130 4000114 4000205 4000043 4000137 4000334 4000143 4000249 4000132 4000011 4000492 4000141 4000160 4000106 4000144 4000146 4000148 4000138 4000267 4000391 4000221 4000152 4000482 4000139 4000155 4000165 4000327 4000181 4000174 4000304 4000198 4000177 4000162 4000176 4000178 4000206 4000187 4000238 4000171 4000159 4000170 4000292 4000191 4000188 4000193 4000222 4000192 4000250 4000207 4000182 4000200 4000214 4000236 4000215 4000285 4000230 4000239 4000212 4000260 4000271 4000263 4000231 4000284 4000220 4000248 4000225 4000307 4000245 4000295 4000240 4000253 4000274 4000204 4000246 4000258 4000232 4000259 4000264 4000315 4000275 4000344 4000270 4000308 4000265 4000289 4000278 4000362 4000302 4000329 4000277 4000261 4000291 4000340 4000313 4000325 4000293 4000319 4000309 4000306 4000332 4000252 4000467 4000311 4000326 4000445 4000330 4000440 4000426 4000310 4000322 4000318 4000359 4000363 4000404 4000351 4000687 4000380 4000388 4000355 4000352 4000357 4000403 4000425 4000361 4000349 4000369 4000383 4000371 4000251 4000429 4000368 4000434 4000405 4000489 4000484A 4000384 4000443 4000377 4000406 4000323 4000387 4000424 4000593 4000532 4000414 4000517 400438 4000432 4000444 4000456 40007060007 4000435 4000431 4000439 4000441 4000446 4000490 4000448 4000450 4000452 4000499 4000453 4000460 4000636 4000626 400054 4000470 4000480 4000596 4000520 4000474 4000486 4000496 4000574 4000502 4000531 4000565 4000513 4000433 4000501 4000506 4000476 4000507 4000508 4000526 4000528 4000521 4000523 4000589 4000522 4000534 4000588 4000525 4000541 4000535 4000542 4000556 4000546 4000538 4000553 4000634 4000561 4000558 4000564 4000575 4000509 4000598 4000569 4000577 4000586 4000579 4000633 4000587 4000563 4000624 4000642 4000590 4000580 4000578 4000599 4000605 4000597 4000594 4000616 4000609 4000603 4000615 4000644 4000611 4000610 4000619 4000608 4000622 4000623 4000628 4000625 4000629 4000632 4000685 4000630 4000658 4000654 4000635 4000657 4000659 4000649 4000646 4000661 4000650 4000656 4000660 4000653 4000668 4000666 4000684 4000677 4000670 4000671 4000673 4000680 4000695 4000697 4000201 4000527 4000543 5000916
• Recalling Firm/ Manufacturer: Philips North America; 222 Jacobs St; Cambridge MA 02141-2296
• For Additional Information Contact: Philips Customer Care Solutions Center; 800-722-9377
• Manufacturer Reason for Recall: While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
• FDA Determined Cause: Device Design
• Action: On November 30, 2023, the firm notified customers of the issue through Urgent Medical Device Correction Letters. Users were instructed to monitor the patient during system movement when Pre-Programed Motion is in use and review the warning and caution guidance information provided with the recall notice, and which is also outlined in the Instructions for Use. Philips will contact you to schedule a time for a field service engineer to visit your site and install a technical solution to resolve this issue. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
• Quantity in Commerce: 359 US; 328 OUS
• Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES