CLASS II ONGOING Device recall · Reported 13 Sep 2023 · FDA Enforcement Report
MultiDiagnost-Eleva recalled by Philips Medical Systems
Philips Medical Systems Nederland B.V is recalling MultiDiagnost-Eleva, distributed nationwide in the US. The recall was initiated on 19 Jul 2023 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-2404-2023
- FDA event ID
- 92855
- Recalling firm
- Philips Medical Systems Nederland B.V, Eindhoven, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Jul 2023
- FDA classified
- 7 Sep 2023
- Reported
- 13 Sep 2023
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Jul 2023 | Recall initiated by company | |
| 7 Sep 2023 | Classified by FDA | +50 days |
| 13 Sep 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Product as listed by the FDA
MultiDiagnost-Eleva
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is MultiDiagnost-Eleva recalled?
Yes. Philips Medical Systems Nederland B.V recalled MultiDiagnost-Eleva on 19 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2404-2023.
Why was it recalled?
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Which lots are affected?
MultiDiagnost-Eleva
Where was it sold?
US Nationwide Distribution
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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