GE Hangwei Medical Systems recalls Definium Tempo and Pro systems due to potential bolts being tightened incorrectly, which could cause parts of the Overhead Tube Suspension assembly to fall. Affected units have specific UDI and System IDs listed in the recall notice.
GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.
GE Hangwei is recalling Definium Tempo and Definium Tempo Pro medical imaging systems because certain bolts might have been tightened incorrectly. This could cause parts of the Overhead Tube Suspension assembly to fall, potentially causing injury during use.
Incorrect torque on bolts in the Overhead Tube Suspension assembly may cause parts of the assembly to fall. This could lead to injury if the falling components strike a person or equipment during medical procedures.
Medical facilities that own or use Definium Tempo and Definium Tempo Pro systems are most at risk. The recall affects specific units identified by their Unique Device Identification (UDI) and System IDs.
Check if your system has a UDI code starting with 01001952781183561122 or similar, and a System ID listed in the provided UDI details. The recall includes specific units with unique identifiers.
Review your system's Unique Device Identification (UDI) and System ID to confirm if it's affected by this recall.
Reach out to GE Hangwei Medical Systems for guidance on next steps if your system is affected.
Incorrect torque on bolts could cause parts of the Overhead Tube Suspension assembly to fall, potentially causing injury during medical procedures.
Check your system's Unique Device Identification (UDI) and System ID against the list provided in the recall notice.
Contact GE Hangwei Medical Systems for guidance on next steps if your system is affected.
We’ve drafted a message you can send GE Hangwei to request your refund or repair — edit it as you like.
Subject: Recall Z-0552-2024 — GE Hangwei GE Hangwei Hello, I own a GE Hangwei that is covered by recall Z-0552-2024 from GE Hangwei. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
