The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1407-2015·Announced 2015-05-06

GE Healthcare Recalls Six Optima XR220 amx Mobile X-Ray Units

GE Healthcare is recalling six Optima XR220 amx mobile X-ray units in the US due to potential mAs accuracy inaccuracies.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a technical inaccuracy in exposure measurement without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GE Healthcare is recalling six units of the Optima XR220 amx Automatic Mobile X-Ray (AMX) Series in the United States. The recall was initiated after an issue was identified with the mAs accuracy check performed on the system.

The identified issue could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 milliseconds. The affected units were distributed to the states of Arizona, Florida, Georgia, Missouri, and Wisconsin. The specific product codes involved are OptimaXR220amx PN 5555000-5 and PN5555000-6.

Healthcare facilities and consumers should contact GE Healthcare for further instructions regarding the recall and potential remediation of the affected devices.

The recalled product

Product
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Manufacturer
GE Healthcare
Category
Medical Device — Diagnostic Imaging
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)

  • OptimaXR220amx PN 5555000-5
  • PN5555000-6

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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