FDA Device recall Z-1487-2020
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044) by Philips North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1487-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-30 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Reason
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.
Identifiers
| code_info | Serial Codes 3217017 200 58 72 CV.170 180 524615 47 211 364 30 3862570/0011 529 S.N. 519 S01H060871 5…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1487-2020%22
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