The System is designed as a modular system with components that include an Overhead Tube Suspensi...
FDA Device Recall #Z-0553-2024 — Class II — November 7, 2023
Recall Summary
| Recall Number | Z-0553-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 7, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Hangwei Medical Systems, Co. LTD |
| Location | Beijing, N/A |
| Product Type | Devices |
| Quantity | 68 units |
Product Description
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 system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
UDI 01001952781183561122100021DX3SS2200214HLSystem ID 205620DEF1; UDI 01001952781183561122100021DX3SS2200210HLSystem ID 602ABZSCOTTSTMPO; UDI 01001952780702651122060021DX3SS2200096HLSystem ID 408885TEMP1; UDI 01001952781183561122080021DX3SS2200158HLSystem ID 303827DEF1; UDI 01001952781183561122100021DX3SS2200199HLSystem ID 561514DEF1; UDI 01001952781183561123020021DX3SS2300053HLSystem ID 727300DEF; UDI 01001952780702651122100021DX3SS2200194HLSystem ID 229340DEF; UDI 01001952780702651122090021DX3SS2200173HLSystem ID 770219DEF1; UDI 01001952780702651122090021DX3SS2200177HLSystem ID 770219DEF2; UDI Not AvailableSystem ID 912530OPT; UDI 01001952781183561122110021DX3SS2200243HLSystem ID 404778STKTEM1; UDI 01001952781183561122100021DX3SS2200185HLSystem ID 208265DEF1; UDI 01001952781183561122080021DX3SS2200141HLSystem ID NMNMHTEMP1; UDI 01001952780702651123020021DX3SS2300054HLSystem ID NMNMHTEMP2; UDI 01001952781183561122050021DX3SS2200071HLSystem ID 847842TEMP; UDI 01001952781183561123060021DX3SS2300164HLSystem ID 913588TEMPO; UDI 01001952781183561122080021DX3SS2200162HLSystem ID 337261DEF1; UDI 01001952781183561122100021DX3SS2200189HLSystem ID 337261DEF2; UDI 01001952780702651123040021DX3SS2300121HLSystem ID 318495DEF1; UDI 01001952780702651123020021DX3SS2300037HLSystem ID 617SH4332; UDI 01001952781183561122110021DX3SS2200239HLSystem ID 248937DEF1; UDI 01001952781183561122110021DX3SS2200238HLSystem ID 313966DEF1; UDI 01001952780702651123070021DX3SS2300193HLSystem ID 906341DEF1; UDI 01001952780702651123010021DX3SS2300029HLSystem ID WH231TEMPO; UDI 01001952780702651122070021DX3SS2200109HLSystem ID 816276TEMPO; UDI 01001952781183561123060021DX3SS2300165HLSystem ID 605310DEF1; UDI 01001952781183561122110021DX3SS2200232HLSystem ID 800439DEFTEM; UDI 01001952780702651122070021DX3SS2200121HLSystem ID 732222DEF110; UDI 01001952780702651122080021DX3SS2200140HLSystem ID 908273DEFTE; UDI 01001952781183561123040021DX3SS2300127HLSystem ID 609463DEF1; UDI 01001952780702651122020021DX3SS2200024HLSystem ID 732222DEF1; UDI 01001952780702651123010021DX3SS2300035HLSystem ID 908735DEF; UDI 01001952780702651123010021DX3SS2300033HLSystem ID 973437DEF1; UDI 01001952780702651123020021DX3SS2300051HLSystem ID 732745RAD; UDI 01001952781183561121070021DX3SS2100170HLSystem ID 914787XRA; UDI 01001952781183561123020021DX3SS2300036HLSystem ID 607273TEMPO1; UDI 01001952780702651121070021DX3SS2100162HLSystem ID 585922DEFTP; UDI 01001952781183561122020021DX3SS2200025HLSystem ID 937523TEMPO; UDI 01001952780702651122080021DX3SS2200142HLSystem ID 405604TEMPO1; UDI 01001952781183561122050021DX3SS2200080HLSystem ID 405271TEMPO; UDI 01001952781183561122100021DX3SS2200193HLSystem ID 405271AHTEMPO; UDI 01001952780702651123010021DX3SS2300017HLSystem ID 405636TEMPO; UDI 01001952780702651122090021DX3SS2200176HLSystem ID 405372TEMPO2; UDI 01001952780702651123040021DX3SS2300100HLSystem ID 580254TEMPO; UDI 01001952780702651122030021DX3SS2200044HLSystem ID 724773ER1; UDI 01001952781183561122050021DX3SS2200079HLSystem ID 272639TEMPO; UDI 01001952781183561122050021DX3SS2200064HLSystem ID 570723TEMPOER; UDI 01001952781183561122010021DX3SS2200005HLSystem ID 605997RADT; UDI 01001952781183561122080021DX3SS2200143HLSystem ID 605835TEMPO; UDI 01001952781183561123050021DX3SS2300159HLSystem ID 605995DEF1; UDI 01001952780702651122070021DX3SS2200119HLSystem ID 605504DEF1; UDI 01001952780702651122100021DX3SS2200184HLSystem ID 605322DEF2; UDI 01001952780702651122070021DX3SS2200104HLSystem ID 605322DEF1; UDI 01001952781183561122080021DX3SS2200147HLSystem ID 605589DEF1; UDI 01001952781183561122100021DX3SS2200207HLSystem ID 915747DEF1; UDI 01001952781183561122110021DX3SS2200235HLSystem ID 915832DEF2; UDI 01001952781183561122060021DX3SS2200095HLSystem ID 915832DEF1; UDI 01001952781183561122110021DX3SS2200219HLSystem ID 210MTBTEMPO; UDI 01001952781183561122110021DX3SS2200226HLSystem ID 210BMCTEMPO; UDI 01001952780702651122110021DX3SS2200229HLSystem ID 210MAHTEMPO; UDI 01001952781183561123010021DX3SS2300034HLSystem ID 801726DEF2; UDI 01001952781183561123050021DX3SS2300140HLSystem ID 801268DEF; UDI 01001952780702651123070021DX3SS2300199HLSystem ID 801842DEF2; UDI 01001952781183561122040021DX3SS2200059HLSystem ID 801855DEF1; UDI 01001952780702651122080021DX3SS2200154HLSystem ID 540731DTMP1; UDI 01001952781183561122070021DX3SS2200116HLSystem ID 804594DEF1; UDI 01001952780702651122050021DX3SS2200083HLSystem ID 540921DTP2; UDI 01001952780702651122040021DX3SS2200058HLSystem ID 757983RM2
Other Recalls from GE Hangwei Medical Systems, Co. LTD
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0552-2024 | Class II | The System is designed as a modular system with... | Nov 7, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.