Portable X-Ray Cart Positioning Arm Bolt May Come Loose and Fall
First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.
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: This is an FDA Class II medical device recall involving a potential hardware failure that could result in patient injury. No illnesses or injuries are reported in the source, making this a theoretical risk-of-harm situation rather than a confirmed injury case.
Plain-English summary
First Source Inc is recalling the First Source Vision M portable cart and platform, which is designed to support X-ray imaging systems and laptop computers. A total of 680 units have been distributed in the United States, Korea, and Serbia.
The bolt that secures the positioning arm to the gas spring may come loose and fall onto a patient. This defect poses a potential injury risk to patients or operators near the equipment.
Users should contact First Source Inc for instructions regarding their equipment.
The recalled product
- Product
- First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
- Manufacturer
- First Source Inc
- Hazard
- loose-bolt
- falling-object
- injury-risk
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 (20)
- UDI-DI N/A
- Serial No. 3009
- 3010
- 3013
- 3014
- 3015
- 3016
- 3017
- 3018
- 3019
- 3020
- 3021
- 3022
- 3023
- 3024
- 3025
- 3026
- 3027
- 3028
- 3029
Distribution
Distributed nationwide across the United States.
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