X-ray System Overhead Crane May Continue Moving Unexpectedly
Carestream Health is recalling certain DRX-Compass/DR-FIT X-ray systems because the overhead tube crane may unexpectedly continue moving after Z-axis motorized buttons are pressed and released, potentially causing injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall involving a functional safety defect. The overhead tube crane could unexpectedly continue moving after button release, potentially causing injury. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Carestream Health, Inc. is recalling certain DRX-Compass/DR-FIT X-ray systems with firmware versions 2.3.2.0 and 2.3.2.4. These systems are used in medical facilities to obtain diagnostic radiographic images to aid physicians with diagnosis. A total of 72 units have been recalled.
The recall was initiated because after pressing and releasing the Z-axis motorized buttons on the tube head display, the overhead tube crane (OTC) could unexpectedly continue moving to a certain distance. This unintended movement could potentially result in injury to personnel or patients.
The affected systems were distributed in the United States and internationally. U.S. distribution includes California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas, and Wisconsin. International distribution includes Argentina, Australia, Brazil, China, Finland, France, India, Italy, Korea, Malaysia, and Poland.
Facilities and individuals with affected systems should contact Carestream Health, Inc. for information regarding this recall.
The recalled product
- Product
- DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240…
- Manufacturer
- Carestream Health, Inc.
- Affected units
- 72
Distribution
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