The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2256-2012·Announced 2012-09-19

GE Healthcare Recalls Optima XR200amx Mobile X-Ray Units Due to Software Issue

GE Healthcare is recalling 254 Optima XR200amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

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: The recall involves a risk-of-harm product (radiographic imaging) where the software defect could lead to improper exposure, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 254 units of the Optima XR200amx mobile general purpose radiographic imaging system in the United States. The recall involves specific part numbers: 5555000-3, 5555000-4, 5555000-5, and 5555000-6. The devices were distributed nationwide.

The recall is due to a software issue that violates 21 CFR 1020.31(a). After an image is taken, if a user selects and clears an additionally displayed screen, the system inhibit is also cleared. This allows the user to take an exposure without the technique factors being displayed.

This recall affects healthcare facilities using the Optima XR200amx for imaging the human head and body. Users should contact GE Healthcare for instructions on resolving the software issue.

The recalled product

Product
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Radiographic Imaging
Hazard
Affected units
254

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 (4)

  • Part Numbers: 5555000-3
  • 5555000-4
  • 5555000-5
  • 5555000-6.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC 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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