The Recall Desk
HighFDA (Devices)·Z-2202-2012·Announced 2012-08-22

Carestream DRX-1 System Battery Recall for Overheating Risk

Carestream Health is recalling DRX-1 system batteries manufactured before June 2012 due to two reported instances of lithium-ion battery overheating that may cause burns.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (burns from overheating) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Carestream Health, Inc. is recalling Carestream DRX-1 System batteries manufactured before June 2012. The recall involves 9,971 units that were distributed worldwide, including in the United States. These batteries may have been sold with the DRX-1 imaging device or as stand-alone accessories.

The recall is being conducted because of two occurrences of lithium-ion battery overheating. This overheating may cause burns to users or nearby individuals.

Consumers and healthcare facilities should stop using the affected batteries immediately. Carestream Health is the recalling firm responsible for addressing this safety issue.

The recalled product

Product
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.
Affected units
9,971

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All DRX-1 batteries manufactured before June 2012.

Distribution

Distributed nationwide across the United States.