GE Definium Tempo X-Ray System Bolts May Loosen and Fall
Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.
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 an FDA Class II recall for a diagnostic medical device with a structural failure risk (bolts loosening, causing overhead assembly components to fall). No injuries or hospitalizations have been reported, and the hazard is potential rather than confirmed in actual use, meeting the criteria for High severity per the rubric.
Plain-English summary
GE Hangwei Medical Systems is recalling certain Definium Tempo and Definium Tempo Pro X-ray systems distributed nationwide. These are modular diagnostic X-ray imaging systems used in medical facilities, with components including an overhead tube suspension, wall stand, table, X-ray generator, and wireless digital detectors.
Incorrect torque has been applied to certain bolts on the Overhead Tube Suspension (OTS) assembly in the recalled units. This may cause the bolts to loosen over time and potentially result in components of the overhead assembly falling.
A total of 134 units were recalled. No injuries have been reported to date. GE Hangwei Medical Systems is notifying customers and recommends immediate inspection of the overhead assembly bolts. Customers should contact the manufacturer for proper inspection and correction procedures.
The recalled product
- Product
- The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
- Manufacturer
- GE Hangwei Medical Systems, Co. LTD
- Hazard
- mechanical-failure
- fall-hazard
- bolt-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)
- UDI 01001952781183561122100021DX3SS2200214HL
- System ID 205620DEF1
- UDI 01001952781183561122080021DX3SS2200165HL
- System ID 205783DEF1
- UDI 01001952781183561122100021DX3SS2200211HL
- System ID 205387DEF1
- UDI 01001952781183561122110021DX3SS2200216HL
- System ID 623ABZARRWTMPO
- UDI 01001952781183561122120021DX3SS2300001HL
- System ID 928263DEF1
- UDI 01001952781183561123040021DX3SS2300103HL
- System ID 520NOGTEMPO
- UDI 01001952781183561122100021DX3SS2200210HL
- System ID 602ABZSCOTTSTMPO
- UDI 01001952781183561122110021DX3SS2200223HL
- System ID 602ABZCNTRLTMPO
- UDI 01001952781183561123030021DX3SS2300082HL
- System ID 209324DEF1
- UDI 01001952781183561123020021DX3SS2300046HL
- System ID 209497DEF1
Distribution
Distributed nationwide across the United States.
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