Mobile Radiographic System Arm May Drop Due to Missing Safety Bolts
GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.
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: This is a Class II recall of a medical device with a risk-of-harm defect. While no injuries have been reported in the source material, the potential for equipment drop poses a significant risk. The hazard requires two concurrent failures—missing bolts and cable failure—to manifest.
Plain-English summary
GE Healthcare has issued a recall of certain Optima XR200/220/240amx mobile digital radiographic systems. The recall affects 53 units distributed worldwide. The systems have model numbers 5555000-3, 5555000-4, and A0659MB.
The recall is due to a defect in systems that have undergone column replacement. Some bolts used in the Column Safety mechanism may be missing. These bolts are critical for the safety system that prevents the X-ray arm from dropping.
If both conditions occur simultaneously—the bolts are missing AND the internal counterpoise cable fails—the Column Safety mechanism will not function properly. This could cause the arm carrying the X-ray tube and collimator to drop downward along the column track, creating a potential hazard to personnel in the vicinity.
Healthcare facilities using affected units should verify that the Column Safety mechanism bolts are present and properly installed. Contact GE Healthcare for inspection and any necessary replacement of missing bolts. Do not operate the system if the safety mechanism cannot be verified as intact.
The recalled product
- Product
- GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- missing-bolts
- equipment-drop
- mechanical-failure
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) 5555000-3: UDI/DI 00840682115278
- Serial Numbers: 260665XR220
- 478757OPT
- 512SDERLM1
- 904244MP5
- 912466AMX2
- 954WRMCDP2
- UDI/DI none
- Serial Numbers: 10523MOB01
- 201418DIG1
- 210297NC200M1
- 229276M200
- 240566P1
- 316858AMX200P1
- 401OPTI3
- 410368WP1
- 443643WP1
- 503251XR200
- 512SDMCP1
- 518243OPT2
Distribution
Distribution scope not specified by the agency.
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