The Recall Desk
HighFDA (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.

What this means for you

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
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 →

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