Multix Fusion system is a radiographic system: Models: Multix Fusion… — Class II medical device recall Z-0297-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-11-07, distributed nationwide. Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, l
| Recall number | Z-0297-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2018-08-03 |
| Classified | 2018-10-30 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2019-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 35 units |
| Serial numbers | 10037, 10039, 10040, 10041, 1176, 1185, 1192, 1220, 40022, 40026, 40027, 40101, 40102, 40104, 40105, 40106, 40109, 40114, 40116, 40117, 40118, 40119, 40125, 40126, 40127 and 10 more |
| Model numbers | 10746665, 10746666, 10746667, 10893300, 7042042, 7042059 |
Product
Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)
Reason for recall
Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0297-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.