Carestream Health, Inc.: DRX Revolution Mobile X-Ray Systems Recalled for Electrical Component Failure

Agency Publication Date: December 1, 2023

Summary

Carestream Health, Inc. has issued a voluntary recall for 3,961 units of the DRX Revolution Mobile X-Ray System due to the unexpected failure of electrical components within the CPI generator. These mobile imaging units are used in hospitals and clinics to provide bedside diagnostic imaging. The defect can cause the device to stop functioning correctly during use, potentially leading to delayed diagnosis or treatment. Consumers should contact Carestream Health or their healthcare facility's biomedical engineering department to determine if their specific unit is included in this global recall.

Risk

The internal electrical components of the X-ray generator can fail unexpectedly, which may cause the system to lose power or fail to produce an X-ray image during a critical procedure. This failure can lead to delays in patient care or the need for repeated radiation exposure.

What You Should Do

Identify if your device is affected by checking the Serial Number and Catalog Number located on the system's identification label. Affected Catalog numbers include 1019397, 1023423, 1030717, 1030725, 1044726, 1060177, 8608754, 1023415, 8610180, and 8618894.
Verify the Serial Number against the extensive list of over 3,000 affected units, which includes numbers ranging from 101 to 4734 (refer to the manufacturer's notification for the complete list).
Check the Unique Device Identifier (UDI-DI) code on the equipment, specifically looking for the sequence starting with (01)60889971019394.
If your device is identified as part of the recall, contact Carestream Health, Inc. immediately at their Rochester, New York headquarters or through your local authorized service representative to arrange for a technical assessment or repair.
Healthcare providers should consult with their internal biomedical or clinical engineering teams to ensure the device is functioning according to specifications until a permanent fix is applied.
For additional questions or to report issues, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer corrective action and technical support

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DRX Revolution Mobile X-Ray System

Model / REF:

1019397

1023423

1030717

1030725

1044726

1060177

8608754

1023415

8610180

8618894

UPC Codes:

60889971019394

Lot Numbers:

Serial No. 101 through 4734 (specific individual units listed in recall text)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93241

Status: Active

Manufacturer: Carestream Health, Inc.

Sold By: Hospitals; Medical centers; Diagnostic imaging clinics

Manufactured In: United States

Units Affected: 3,961 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your device is affected by checking the Serial Number and Catalog Number located on the system's identification label. Affected Catalog numbers include 1019397, 1023423, 1030717, 1030725, 1044726, 1060177, 8608754, 1023415, 8610180, and 8618894.

Verify the Serial Number against the extensive list of over 3,000 affected units, which includes numbers ranging from 101 to 4734 (refer to the manufacturer's notification for the complete list).

Check the Unique Device Identifier (UDI-DI) code on the equipment, specifically looking for the sequence starting with (01)60889971019394.

If your device is identified as part of the recall, contact Carestream Health, Inc. immediately at their Rochester, New York headquarters or through your local authorized service representative to arrange for a technical assessment or repair.

Healthcare providers should consult with their internal biomedical or clinical engineering teams to ensure the device is functioning according to specifications until a permanent fix is applied.

For additional questions or to report issues, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.