DRX Revolution Mobile X-Ray System

FDA device recall Z-0437-2024 · posted 2023-12-01 · Open, Classified

Recall details

Recalling firm

Carestream Health, Inc.

Reason for recall

Unexpected failure of electrical components within the CPI generator.

Action taken

Consignees were sent a "MEDICAL DEVICE FIELD CORRECTIVE ACTION" on 10/02/2023. This notice requested that consignees inform all personnel that utilize the affected devices of the recall notice and to return the provided Consignee Notification Acknowledgement form completed. If a failure similar to the one associated with this recall event were to occur, users should move the system away from patients and staff, the system should be identified as inoperable, and a call should be made to Carestream Customer Care at 1-800-328-2910, your local service support number, or your Carestream Health Authorized Representative to schedule a service call. Customers with any questions are to call the Carestream Customer Care Center. If you have any questions or concerns please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24-hour basis. Outside of the U.S., please call your local Carestream Service support number.

Root cause

Component design/selection

Status

Open, Classified

Product code

IZL

Quantity affected

3,961 units

Distribution

Worldwide Distribution: US (Nationwide Distribution); and OUS (Foreign): Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Dominican R

Date initiated

2023-10-02

Date posted

2023-12-01

Location

Rochester, NY

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