Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
This recall has been terminated (originally issued December 30, 2019).
- Company
- Philips North America, Llc
- Recall Initiated
- December 30, 2019
- Terminated
- November 17, 2022
- Recall Number
- Z-1487-2020
- Quantity
- 70
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Lot / Code Info
Serial Codes 3217017 200 58 72 CV.170 180 524615 47 211 364 30 3862570/0011 529 S.N. 519 S01H060871 505/0050114 S01H057274 01H077213 530 532 S01HA52566 348 476 320 481 467 284 352 359 459 73*004 733 536 CV.474 454 49 281 51 186 122 250 37 22 CV.312 296 373 CV.596 176 30 580 279
Root Cause
Component design/selection
Action Taken
On December 30, 2019, the firm notified customers via Medical Device Correction letter. Customers were informed of the product issue and advised to do the following: If the capacitor of the Velara X-Ray fails as described (capacitor failure after large number of surges in a short period of time), please switch off the system, take it out of service immediately, and contact your local Philips representative. The firm will be resolving the issue by replacing a Printed Circuit Board (PCB) in the convertor, which prevents the capacitor from failing. PCB replacements started in January 2020. Customers will be contacted by their local Philips representatives to schedule a date for the PCB replacement. Customers with further questions should contact the Technical Support Line: 1-800-722-9377.