FDA Medical Device Recalls (openFDA)
Philips North America, LLC: OmniDiagnost Eleva System codes 708028 708027
- Recall number
- Z-1490-2020
- Recalling firm
- Philips North America, LLC
- Product
- OmniDiagnost Eleva System codes 708028 708027
- Status
- Terminated
- Initiated
- 2019-12-30
- Posted
- not on file
- Terminated
- 2022-11-17
- 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.
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 69
- Distribution
- Nationwide domestic distribution. Foreign distribution worldwide.
- Lot, serial or model codes
- Serial codes 152 49 514 179 611 C@23273 46 560 555 464 14 90 198 15 326 143*003 451 267 FR90-111 417 59 390 164 135 23 143 80 219 24 78 73 15 79 109 624 71 44 576 70 460 62 98 63 620 147 100 68 122 422 12 54 490 97 138 20 130 67 ON100031011SN273 241 435 125 89 47 17 33 134 574
- 510(k) numbers
- ["K032046"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28