First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Recall
- Recall Number
- Z-2246-2024
- Event Number
- 94744
- Firm
- First Source Inc
- FEI Number
- 3004063527
- Product Code
- IZL
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 9, 2024
- Posted
- July 1, 2024
- Address
- 3495 Winton Pl, Bldg E Ste 1, Rochester, NY, 14623-2824
Description
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Consignees were emailed an URGENT: MEDICAL DEVICE RECALL notification, dated 5/29/24. The notice instructs consignees to follow the recommended preventive maintenance schedule and visually check the device before use to identify if the affected bolt is coming loose. The recalling firm is currently testing a spring clip which will keep the bolt from falling out and will send this part to customers at no charge once approved. Consignees are asked to return the provided response form. Consignees with any questions can contact the firm by email at [email protected] or by phone at 1-800-349-5980 (option 2) from 9:00 AM to 5:00 PM EST from Monday through Friday.
Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, IL, IN, LA, MA, MD, MI, MO, MS, NC, NY, OK, PA, TN, TX, & VA. The countries of Korea & Serbia.
680 units