Recall Z-2247-2024— First Source Inc

Name: FDA recall Z-2247-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-09

Class II · Ongoing

Class II FDA medical device recall by First Source Inc, initiated 2024-05-09. It names one FDA 510(k) clearance: K221081. Product: First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.. Reason: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient..

Recalling firm: First Source Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-05-09
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K221081 — iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemFirst Source, Inc.·cleared 2022-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.