Date Initiated by Firm |
June 27, 2018 |
Date Posted |
August 17, 2018 |
Recall Status1 |
Terminated 3 on April 30, 2024 |
Recall Number |
Z-2859-2018 |
Recall Event ID |
80577 |
510(K)Number |
K090625
|
Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
|
Product |
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 |
Code Information |
Serial Numbers:
488713/SN11000577
488714/SN11000572
444623/SN10000136
480503/SN11000473
480504/SN11000478
410040/SN08000021
422832/SN09000061
462407/SN10000363
448130/SN10000008
464981/SN10000471
455752/SN10000200
454061/SN10000216
426292/SN09000386
455546/SN10000143
420090/SN09000018
474817/SN11000080
474238/SN11000042
461799/SN10000347
455621/SN10000163
471148/SN11000122
471147/SN11000120
482904/SN11000375
482905/SN11000373
482903/SN11000379
440249/SN09000347
481021/SN11000446
487808/SN11000526
441778/SN09000452
432989/SN09000285
478307/SN12000004
476338/SN12000026
476034/SN12000027
422536/SN09000199
486638/SN11000494
466808/SN10000464
462593/SN10000439
471150/SN10000660
478233/SN11000233
473897/SN11000165
482501/SN11000527
453200/SN10000133
456093/SN10000204
461979/SN10000701
461976/SN10000704
443093/SN09000454
445110/SN09000461
16750755
477524/SN11000434
475932/SN11000341
475866/SN11000350
451542/SN10000098
442534/SN09000423
443443/SN09000420
484558/SN11000525
479928/SN11000287
466029/SN10000420
472613/SN11000162
480061/SN11000474
453085/SN10000125
467927/SN10000713
450779/SN10000062
480881/SN11000274
476835/SN11000179
442005/SN10000298
444627/SN10000142
442310/SN10000149
478181/SN11000455
481142/SN11000318
467348/SN11000207
441637/SN09000354
441638/SN09000356
464863/SN10000533
464880/SN10000714
421977/SN09000115
449365/SN10000110
464755/SN10000391
430355/SN09000214
451543/SN10000100
***Added 5/6/21***
SN15000449 |
Recalling Firm/ Manufacturer |
Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany
|
For Additional Information Contact |
Philips Service Engineer 40-50782110
|
Manufacturer Reason for Recall |
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
|
FDA Determined Cause 2 |
Device Design |
Action |
On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative. |
Distribution |
US Nationwide; International to 66 countries |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
|