First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

FDA device recall Z-2246-2024 · posted 2024-07-01 · Open, Classified

Recall details

Recalling firm

First Source Inc

Reason for recall

Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

Action taken

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 support@fsimed.com or by phone at 1-800-349-5980 (option 2) from 9:00 AM to 5:00 PM EST from Monday through Friday.

Root cause

Device Design

Status

Open, Classified

Product code

IZL

Quantity affected

680 units

Distribution

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.

Date initiated

2024-05-09

Date posted

2024-07-01

Location

Rochester, NY