CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report
OmniDiagnost Eleva System codes recalled by Philips North America
Philips North America is recalling OmniDiagnost Eleva System codes 708028 708027, distributed nationwide in the US. The recall was initiated on 30 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1490-2020
- FDA event ID
- 84756
- Recalling firm
- Philips North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Dec 2019
- FDA classified
- 13 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Dec 2019 | Recall initiated by company | |
| 13 Mar 2020 | Classified by FDA | +74 days |
| 25 Mar 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
OmniDiagnost Eleva System codes 708028 708027
Where it was distributed
Nationwide domestic distribution. Foreign distribution worldwide.
Questions about this recall
Is OmniDiagnost Eleva System codes 708028 708027 recalled?
Yes. Philips North America recalled OmniDiagnost Eleva System codes 708028 708027 on 30 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1490-2020.
Why was it 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.
Which lots are affected?
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
Where was it sold?
Nationwide domestic distribution. Foreign distribution worldwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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