Integris Allura 15 & 12 recall
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Why was Integris Allura 15 & 12 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
- Recalling firm
- Philips North America, LLC
- Quantity
- 70
- Distribution
- Nationwide domestic distribution. Foreign distribution worldwide.
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)