Agency classClass IIOur severity:High FDA (Devices)·Z-0813-2025·Announced 2025-01-15

Medical radiographic system arm drop hazard due to missing safety bolts

GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.

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: FDA Class II recall with risk of equipment failure causing potential serious injury from arm drop. No injuries have been reported. This meets the High severity criterion: risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems, LLC is recalling certain Optima XR240amx Mobile Digital Radiographic Systems that have had column replacement performed. These systems may have missing bolts in the Column Safety mechanism.

If the bolts are missing and the internal counterpoise cable fails, the Column Safety mechanism will not function properly. This could cause the arm containing the X-ray tube and collimator to drop downward on the column track, posing a hazard to patients and medical staff.

The recalled systems have been distributed worldwide. Approximately 120 units are affected by this recall.

The recalled product

Product: GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Diagnostic Imaging
Hazard: equipment-drop
mechanical-failure
Affected units: 120

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)

1) 5555000-27: UDI/DI 840682122351
Serial Numbers: 228867XR240
252847PP241
281274OPT1
281338CL240
281VHVXR240
305682DIG1
305682DIG3
305KEN240B
401OPTI2
405949OPT1
408559XRDR7
413447OPT1
419251OPT
419690DP1
504842XR242
602344240A
602344MARY240
713440DP2
713440DP3

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems, 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 3 products in this recall →

Same manufacturer · GE Medical Systems, LLC

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