The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1406-2015·Announced 2015-05-06

GE Healthcare Recalls Optima XR200 amx Mobile X-Ray Units

GE Healthcare is recalling six Optima XR200 amx mobile X-ray units in the US due to potential mAs accuracy issues that may affect exposure times.

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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare is recalling six units of the Optima XR200 amx Automatic Mobile X-Ray (AMX) Series in the United States. The recall involves units distributed to the states of Arizona, Florida, Georgia, Missouri, and Wisconsin.

The recall is due to an identified issue with the mAs accuracy check performed on the system. This issue could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 milliseconds. The affected units are identified by part numbers 5555000-3 and 5555000-4.

This recall is classified as Class II by the FDA. Consumers and healthcare facilities should contact GE Healthcare for further instructions regarding the affected equipment.

The recalled product

Product
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
Manufacturer
GE Healthcare
Category
Medical Device — Imaging Equipment
Hazard
Affected units
6

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 (2)

  • OptimaXR200amx PN 5555000-3
  • PN5555000-4

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare 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 3 products in this recall →

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