CLASS II Device recall · Reported 22 Aug 2012 · FDA Enforcement Report
Carestream DRX-1 System Battery recalled by Carestream Health
Carestream Health is recalling Carestream DRX-1 System Battery, distributed nationwide in the US. The recall was initiated on 12 Jun 2012 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-2202-2012
- FDA event ID
- 62310
- Recalling firm
- Carestream Health, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2012
- FDA classified
- 13 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 12 Jun 2012 | Recall initiated by company | |
| 13 Aug 2012 | Classified by FDA | +62 days |
| 22 Aug 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
Where it was distributed
Worldwide Distribution, including Nationwide (USA).
Questions about this recall
Is Carestream DRX-1 System Battery recalled?
Yes. Carestream Health recalled Carestream DRX-1 System Battery on 12 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-2202-2012.
Why was it recalled?
Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.
Which lots are affected?
All DRX-1 batteries manufactured before June 2012.
Where was it sold?
Worldwide Distribution, including Nationwide (USA).
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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