The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2246-2024·Announced 2024-07-10

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.

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: 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
Category
Medical Device — Portable imaging equipment
Hazard
Affected units
680

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.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 2 recalled by First Source Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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