GE Hangwei Medical Systems, Co. LTD: Definium Tempo X-Ray Systems Recalled for Falling Hazard

Agency Publication Date: December 14, 2023

Summary

GE HealthCare has recalled 202 units of the Definium Tempo and Definium Tempo Pro Overhead Tube Suspension (OTS) X-ray systems due to a manufacturing defect. Certain bolts on these modular imaging systems may have been tightened with incorrect torque during assembly, which could cause components to loosen over time. This defect can lead to elements of the overhead assembly unexpectedly falling, potentially causing serious injury to patients or medical staff. Affected units were distributed nationwide across the United States between 2021 and 2023.

Risk

Incorrectly tightened bolts can cause the overhead tube suspension assembly to become unstable and fall during medical procedures, posing a direct impact and crushing risk to anyone positioned beneath the equipment.

What You Should Do

Locate the System ID and UDI (Unique Device Identifier) on your Definium Tempo or Definium Tempo Pro modular X-ray system to determine if your unit is affected.
Check your System ID against the list of 202 affected units, which includes IDs such as 205620DEF1, 602ABZSCOTTSTMPO, 303827DEF1, 561514DEF1, 727300DEF, and others listed in the recall documentation.
Identify the UDI on the device labeling; affected codes include identifiers such as 01001952781183561122100021DX3SS2200214HL and 01001952781183561122100021DX3SS2200210HL.
If you identify an affected system, contact your healthcare provider or GE HealthCare immediately to schedule a technical inspection and corrective service to ensure all bolts are torqued to the correct specifications.
Contact GE HealthCare or your local service representative for further instructions regarding the safe operation of the device until a technician can verify the assembly's integrity.
For additional questions, contact the FDA medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

System inspection and re-torque of bolts.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Definium Tempo and Definium Tempo Pro Overhead Tube Suspension (OTS) System (Z-0552-2024)

Model / REF (134):

System ID 205620DEF1

System ID 205783DEF1

System ID 205387DEF1

System ID 623ABZARRWTMPO

System ID 928263DEF1

System ID 520NOGTEMPO

System ID 602ABZSCOTTSTMPO

System ID 602ABZCNTRLTMPO

System ID 209324DEF1

System ID 209497DEF1

System ID 303827DEF1

System ID 970242DEF1

System ID 303457DEF1

System ID 860545TEMPO1

System ID 860545TEMPO2

System ID 203838TEMPO

System ID 860889TEMPO

System ID 202444DEF2

System ID 202877TEM1

System ID 813681DEF1

System ID AHMGCTEM1

System ID 305222DEF1

System ID 561495DEF1

System ID MDEDTEMPO

System ID 407530DEF1

System ID 863680TEMP

System ID 305DLTEMPO

System ID 904BURGRAD1

System ID 407269DEF1

System ID NAEDTEMPO

System ID 561514DEF1

System ID 850DEFBP

System ID 727300DEF

System ID 404251DEF2

System ID 912530OPT

System ID 404778STKTEM1

System ID 804333DEF1

System ID 208265DEF1

System ID NMNMHTEMP1

System ID 847842TEMP

System ID 765298DEF1

System ID 317887TEMPO

System ID 317621DEF1

System ID 812283DEF1

System ID 785877DEF1

System ID 913588TEMPO

System ID 337261DEF1

System ID 337261DEF2

System ID 508363TEMPO

System ID 269789DEF1

Date Ranges: Sold between 2021 and 2023

Product: Definium Tempo and Definium Tempo Pro Overhead Tube Suspension (OTS) System (Z-0553-2024)

Model / REF (68):

System ID 205620DEF1

System ID 602ABZSCOTTSTMPO

System ID 408885TEMP1

System ID 303827DEF1

System ID 561514DEF1

System ID 727300DEF

System ID 229340DEF

System ID 770219DEF1

System ID 770219DEF2

System ID 912530OPT

System ID 404778STKTEM1

System ID 208265DEF1

System ID NMNMHTEMP1

System ID NMNMHTEMP2

System ID 847842TEMP

System ID 913588TEMPO

System ID 337261DEF1

System ID 337261DEF2

System ID 318495DEF1

System ID 617SH4332

System ID 248937DEF1

System ID 313966DEF1

System ID 906341DEF1

System ID WH231TEMPO

System ID 816276TEMPO

System ID 605310DEF1

System ID 800439DEFTEM

System ID 732222DEF110

System ID 908273DEFTE

System ID 609463DEF1

System ID 732222DEF1

System ID 908735DEF

System ID 973437DEF1

System ID 732745RAD

System ID 914787XRA

System ID 607273TEMPO1

System ID 585922DEFTP

System ID 937523TEMPO

System ID 405604TEMPO1

System ID 405271TEMPO

System ID 405271AHTEMPO

System ID 405636TEMPO

System ID 405372TEMPO2

System ID 580254TEMPO

System ID 724773ER1

System ID 272639TEMPO

System ID 570723TEMPOER

System ID 605997RADT

System ID 605835TEMPO

System ID 605995DEF1

Date Ranges: Sold between 2021 and 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93479

Status: Active

Manufacturer: GE Hangwei Medical Systems, Co. LTD

Sold By: GE HealthCare Authorized Dealers

Manufactured In: China

Units Affected: 2 products (134 units; 68 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate the System ID and UDI (Unique Device Identifier) on your Definium Tempo or Definium Tempo Pro modular X-ray system to determine if your unit is affected.

Check your System ID against the list of 202 affected units, which includes IDs such as 205620DEF1, 602ABZSCOTTSTMPO, 303827DEF1, 561514DEF1, 727300DEF, and others listed in the recall documentation.

Identify the UDI on the device labeling; affected codes include identifiers such as 01001952781183561122100021DX3SS2200214HL and 01001952781183561122100021DX3SS2200210HL.

If you identify an affected system, contact your healthcare provider or GE HealthCare immediately to schedule a technical inspection and corrective service to ensure all bolts are torqued to the correct specifications.

Contact GE HealthCare or your local service representative for further instructions regarding the safe operation of the device until a technician can verify the assembly's integrity.

For additional questions, contact the FDA medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Definium Tempo and Definium Tempo Pro Overhead Tube Suspension (OTS) System (Z-0552-2024)

Model / REF (134):

System ID 205620DEF1

System ID 205783DEF1

System ID 205387DEF1

System ID 623ABZARRWTMPO

System ID 928263DEF1

System ID 520NOGTEMPO

System ID 602ABZSCOTTSTMPO

System ID 602ABZCNTRLTMPO

System ID 209324DEF1

System ID 209497DEF1

System ID 303827DEF1

System ID 970242DEF1

System ID 303457DEF1

System ID 860545TEMPO1

System ID 860545TEMPO2

System ID 203838TEMPO

System ID 860889TEMPO

System ID 202444DEF2

System ID 202877TEM1

System ID 813681DEF1

System ID AHMGCTEM1

System ID 305222DEF1

System ID 561495DEF1

System ID MDEDTEMPO

System ID 407530DEF1

System ID 863680TEMP

System ID 305DLTEMPO

System ID 904BURGRAD1

System ID 407269DEF1

System ID NAEDTEMPO

System ID 561514DEF1

System ID 850DEFBP

System ID 727300DEF

System ID 404251DEF2

System ID 912530OPT

System ID 404778STKTEM1

System ID 804333DEF1

System ID 208265DEF1

System ID NMNMHTEMP1

System ID 847842TEMP

System ID 765298DEF1

System ID 317887TEMPO

System ID 317621DEF1

System ID 812283DEF1

System ID 785877DEF1

System ID 913588TEMPO

System ID 337261DEF1

System ID 337261DEF2

System ID 508363TEMPO

System ID 269789DEF1

Date Ranges: Sold between 2021 and 2023

Product: Definium Tempo and Definium Tempo Pro Overhead Tube Suspension (OTS) System (Z-0553-2024)

Model / REF (68):

System ID 205620DEF1

System ID 602ABZSCOTTSTMPO

System ID 408885TEMP1

System ID 303827DEF1

System ID 561514DEF1

System ID 727300DEF

System ID 229340DEF

System ID 770219DEF1

System ID 770219DEF2

System ID 912530OPT

System ID 404778STKTEM1

System ID 208265DEF1

System ID NMNMHTEMP1

System ID NMNMHTEMP2

System ID 847842TEMP

System ID 913588TEMPO

System ID 337261DEF1

System ID 337261DEF2

System ID 318495DEF1

System ID 617SH4332

System ID 248937DEF1

System ID 313966DEF1

System ID 906341DEF1

System ID WH231TEMPO

System ID 816276TEMPO

System ID 605310DEF1

System ID 800439DEFTEM

System ID 732222DEF110

System ID 908273DEFTE

System ID 609463DEF1

System ID 732222DEF1

System ID 908735DEF

System ID 973437DEF1

System ID 732745RAD

System ID 914787XRA

System ID 607273TEMPO1

System ID 585922DEFTP

System ID 937523TEMPO

System ID 405604TEMPO1

System ID 405271TEMPO

System ID 405271AHTEMPO

System ID 405636TEMPO

System ID 405372TEMPO2

System ID 580254TEMPO

System ID 724773ER1

System ID 272639TEMPO

System ID 570723TEMPOER

System ID 605997RADT

System ID 605835TEMPO

System ID 605995DEF1

Date Ranges: Sold between 2021 and 2023