| | Class 2 Device Recall Azurion R2.1 |  |
| Date Initiated by Firm | February 06, 2024 |
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| Date Posted | February 22, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1178-2024 |
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| Recall Event ID |
93966 |
| 510(K)Number | K200917 |
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| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures
Models:
(1) 722223,
(2) 722224,
(3) 722225,
(4) 722226 |
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| Code Information |
US:
(1) Model 722223
SN: 580 (01)00884838099241(21)580
(2) Model: 722224
SN: UDI:
1518 (01)00884838099258(21)1518
1317 (01)00884838099258(21)1317
1221 (01)00884838099258(21)1221
845 (01)00884838099258(21)845
974 (01)00884838099258(21)974
905 (01)00884838099258(21)905
(3) Model: 722225
227 (01)00884838099265(21)227
(4) Model: 722226
441 (01)00884838099272(21)441
398 (01)00884838099272(21)398
OUS:
179 (01)00884838099265(21)179
145 (01)00884838099265(21)145
223 (01)00884838099265(21)223
226 (01)00884838099265(21)226
232 (01)00884838099265(21)232
196 (01)00884838099265(21)196
159 (01)00884838099265(21)159
200 (01)00884838099265(21)200
234 (01)00884838099265(21)234
206 (01)00884838099265(21)206.
412 (01)00884838099272(21)412
425 (01)00884838099272(21)425
420 (01)00884838099272(21)420
355 (01)00884838099272(21)355
393 (01)00884838099272(21)393
407 (01)00884838099272(21)407
402 (01)00884838099272(21)402
527 (01)00884838099272(21)527
479 (01)00884838099272(21)479
509 (01)00884838099272(21)509
460 (01)00884838099272(21)460
505 (01)00884838099272(21)505
513 (01)00884838099272(21)513
485 (01)00884838099272(21)485
364 (01)00884838099272(21)364
507 (01)00884838099272(21)507
577 (01)00884838099272(21)577
476 (01)00884838099272(21)476
515 (01)00884838099272(21)515
596 (01)00884838099272(21)596
598 (01)00884838099272(21)598
521 (01)00884838099272(21)521
455 (01)00884838099272(21)455
589 (01)00884838099272(21)589
575 (01)00884838099272(21)575
522 (01)00884838099272(21)522
540 (01)00884838099272(21)540.
506 (01)00884838099241(21)506
550 (01)00884838099241(21)550
613 (01)00884838099241(21)613
121 (01)00884838099241(21)121
630 (01)00884838099241(21)630
474 (01)00884838099241(21)474
614 (01)00884838099241(21)614
612 (01)00884838099241(21)612
523 (01)00884838099241(21)523
517 (01)00884838099241(21)517
554 (01)00884838099241(21)554
450 (01)00884838099241(21)450
542 (01)00884838099241(21)542
623 (01)00884838099241(21)623
475 (01)00884838099241(21)475
547 (01)00884838099241(21)547
397 (01)00884838099241(21)397
586 (01)00884838099241(21)586
42 (01)00884838099241(21)42
492 (01)00884838099241(21)492
427 (01)00884838099241(21)427
520 (01)00884838099241(21)520
708 (01)00884838099241(21)708
524 (01)00884838099241(21)524
497 (01)00884838099241(21)497
519 (01)00884838099241(21)519
394 (01)00884838099241(21)394
600 (01)00884838099241(21)600.
1154 (01)00884838099258(21)1154
1438 (01)00884838099258(21)1438
1351 (01)00884838099258(21)1351
1139 (01)00884838099258(21)1139
1326 (01)00884838099258(21)1326
1391 (01)00884838099258(21)1391
1075 (01)00884838099258(21)1075
1281 (01)00884838099258(21)1281
1497 (01)00884838099258(21)1497
802 (01)00884838099258(21)802
1553 (01)00884838099258(21)1553
1401 (01)00884838099258(21)1401
1348 (01)00884838099258(21)1348
1350 (01)00884838099258(21)1350
1367 (01)00884838099258(21)1367
1407 (01)00884838099258(21)1407
1181 (01)00884838099258(21)1181
1365 (01)00884838099258(21)1365
1503 (01)00884838099258(21)1503
455 (01)00884838099258(21)455
1489 (01)00884838099258(21)1489
1342 (01)00884838099258(21)1342
1666 (01)00884838099258(21)1666
1714 (01)00884838099258(21)1714
1673 (01)00884838099258(21)1673
1658 (01)00884838099258(21)1658
1733 (01)00884838099258(21)1733
1741 (01)00884838099258(21)1741
1173 (01)00884838099258(21)1173
1566 (01)00884838099258(21)1566
915 (01)00884838099258(21)915
1713 (01)00884838099258(21)1713
1688 (01)00884838099258(21)1688
936 (01)00884838099258(21)936
1602 (01)00884838099258(21)1602
1588 (01)00884838099258(21)1588
1193 (01)00884838099258(21)1193
1586 (01)00884838099258(21)1586
1665 (01)00884838099258(21)1665
1609 (01)00884838099258(21)1609
1463 (01)00884838099258(21)1463
969 (01)00884838099258(21)969
1280 (01)00884838099258(21)1280
1402 (01)00884838099258(21)1402
1598 (01)00884838099258(21)1598
1624 (01)00884838099258(21)1624
1537 (01)00884838099258(21)1537
1645 (01)00884838099258(21)1645
1355 (01)00884838099258(21)1355
1349 (01)00884838099258(21)1349
1736 (01)00884838099258(21)1736
1505 (01)00884838099258(21)1505
1664 (01)00884838099258(21)1664
1711 (01)00884838099258(21)1711
1862 (01)00884838099258(21)1862
1708 (01)00884838099258(21)1708
1447 (01)00884838099258(21)1447
1786 (01)00884838099258(21)1786
1428 (01)00884838099258(21)1428
|
Recalling Firm/
Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
|
Manufacturer Reason
for Recall | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Philips notified U.S customers by Urgent Medical Device Correction letter on 06-Feb-2024 via certified mailing via United States Postal Service. " Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations.
Letter states reason for recall, health risk, and action to take:
Circulate this Letter to all clinical staff and any service personnel that may service the system so that they are aware of the issue.
"
Keep this Urgent Medical Device Correction Letter with the documentation of the system until Philips implements the correction in your system.
"
If the Certeray generator fails, please stop using the system and contact the Customer Care Solutions Center.
"
Place a copy of this Letter in a visible place in the Control and Technical rooms (e.g., posted on the door).
"
Please complete and return the attached response form (on page 3) to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction and understanding of the issue and required actions to be taken.
5.
Actions planned by Philips IGTS to correct the problem
As a remedy, Philips will replace the Power Inverter in the Azurion generator cabinet in all affected Azurion systems through the implementation of Field Change Order (FCO72200544).
If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
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| Quantity in Commerce | 10 units US; 124 units OUS |
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| Distribution | Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia,
Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel,
Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia,
Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland,
Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain,
Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom. |
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| 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 = OWB
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