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U.S. Department of Health and Human Services

Class 2 Device Recall Omnidiagnost

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 Class 2 Device Recall Omnidiagnostsee related information
Date Initiated by FirmFebruary 28, 2019
Create DateMarch 23, 2019
Recall Status1 Terminated 3 on August 03, 2020
Recall NumberZ-1054-2019
Recall Event ID 82313
510(K)NumberK982993 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductOmnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
Code Information Serial numbers 1 2 3 4 7 9 10 11 12 13 14 15 16 17 18 19 20 22 23 24 25 26 27 28 29 30 31 32 33 34 36 38 39 41 42 44 46 47 48 49 50 51 52 53 54 56 58 60 61 62 64 65 66 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 94 95 96 97 98 101 102 103 104 104 106 107 108 109 110 111 111 112 113 115 116 117 118 118 119 120 121 123 123 124 126 127 128 129 130 131 132 133 134 135 135 136 137 138 139 140 142 143 145 146 146 147 148 149 150 151 152 153 154 156 157 158 159 161 164 165 167 173 183 195 198 199 216 217 227 251 253 259 274 281 286 297 317 323 327 333 336 340 348 353 353 358 369 378 380 390 391 393 402 421 423 426 428 438 441 466 471 473 474 481 486 498 504 514 520 530 570 574 592 598 608 664 1489 1529 3019 13124 38351 50428 76596 76948 82655 83871 83958 85163 86113 86303 86326 9341573 41355410 4163250111 708023019087 970478028909 _000364 _073 _082 _146 _302 _332 _345 _364 _371 ~~~~~~~~~~1 ~~~1 096B 1 1*015 112 11591 12 122 1232 126% 131 13310 136 14*009-Omni 141% 163 175 175 178 182 185 190 201 202 210 221 224 225 237 248 26 266 268 275 280 282 284 294 306 319 324 3243 326 3278012607 339 355 365 370 3797350-9 381 389 392 3A57204 401 4042910/000134 407 411 413554106 416 4188010/0171 419 4349690/000217 436 447 463 4665620/000374 4665620/355 4700180000326 4831320/480 60 609 66 68 708023015453 708023015995 708023018193 7080231896 70802322 7080235106 710376025944 78 8 83 84850 86549 86965 86977 87% 87164 89 90 96 97 98 99 C@20236 C@20238 C@20239 C@20241 C@20286 C@21319 C@21325 C@21338 C@21339 C@21353 C@21388 C@21389 C@21390 C@21398 C@21402 C@21406 C@21414 C@22528 C@22599 C@226 C@98168 C@99218 C@99224 GEN023210 GEN023233 M16331 M17264 M19163 M19164 M19169 M19269 M20825 M21186 M22124 S100000980/000001 S100002676/000001 S100002705/000001 S103815/1 S1048831 S3F000861A/117337 S3F000862A/117338 SN98170 URF.092 URF.130 URF.186 URF.218 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactRoland Telson
978-659-7275
Manufacturer Reason
for Recall		The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
FDA Determined
Cause 2		Component design/selection
ActionOn February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Philips representative to schedule the inspection. Philip's action will start effective from March 2019. If you need further information or support concerning this issue, please contact your local Philips representative.
Quantity in Commerce1696
DistributionUS Nationwide domestic distribution, and worldwide international distribution.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAA
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