GE Hangwei recalls Definium Tempo and Pro systems due to potential bolts being tightened incorrectly, which could cause parts of the Overhead Tube Suspension to fall. Affected units have specific UDI codes 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 Pro medical imaging systems because certain bolts might be tightened incorrectly, potentially causing parts of the Overhead Tube Suspension to fall. This could lead to injury if the falling components hit someone.
Incorrect torque on bolts in the Overhead Tube Suspension assembly could cause parts to become loose and fall. If these components fall during use, they might hit people or equipment, causing injury.
Medical professionals using the Definium Tempo and Pro systems are most at risk. Patients and staff in facilities with these systems may also be affected if the Overhead Tube Suspension falls.
Check for specific UDI codes listed in the recall notice, such as UDI 01001952781183561122100021DX3SS2200214HL or System ID 205620DEF1. The products are used in medical imaging systems like the Discovery XR656 HD.
Look for the unique device identifiers (UDIs) listed in the recall notice, such as UDI 01001952781183561122100021DX3SS2200214HL.
Reach out to GE Hangwei for assistance with the recall process if you have the UDI codes listed in the notice.
Incorrect torque on bolts in the Overhead Tube Suspension assembly could cause parts to fall, potentially leading to injury if components hit people.
Check for specific UDI codes listed in the recall notice, such as UDI 01001952781183561122100021DX3SS2200214HL or System ID 205620DEF1.
Contact GE Hangwei for assistance with the recall process if you have the UDI codes listed in the notice.
We’ve drafted a message you can send GE Hangwei to request your refund or repair — edit it as you like.
Subject: Recall Z-0553-2024 — GE Hangwei GE Hangwei Hello, I own a GE Hangwei that is covered by recall Z-0553-2024 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.
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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.
