CLASS II Device recall · Reported 4 Mar 2015 · FDA Enforcement Report
Philips Multi Diagnost Eleva with FlatDetector recalled
Philips Medical Systems is recalling Philips Multi Diagnost Eleva with FlatDetector, distributed nationwide in the US. The recall was initiated on 14 Oct 2013 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-1045-2015
- FDA event ID
- 69870
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Oct 2013
- FDA classified
- 26 Feb 2015
- Reported
- 4 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Oct 2013 | Recall initiated by company | |
| 26 Feb 2015 | Classified by FDA | +500 days |
| 4 Mar 2015 | 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
The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
Product as listed by the FDA
Philips Multi Diagnost Eleva with FlatDetector
Where it was distributed
Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.
Nationwide ArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIowaIllinoisKansasKentuckyLouisianaMichiganMissouriMississippiNorth CarolinaNew YorkOhioPennsylvania
Questions about this recall
Is Philips Multi Diagnost Eleva with FlatDetector recalled?
Yes. Philips Medical Systems recalled Philips Multi Diagnost Eleva with FlatDetector on 14 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-1045-2015.
Why was it recalled?
The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
Which lots are affected?
Product Code: 708037
Where was it sold?
Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.
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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