Z-0297-2019 Class II Terminated
FDA device recall Z-0297-2019 was initiated by Siemens Medical Solutions USA, Inc on Aug 3, 2018 and is designated Class II. 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… The recall status is terminated (terminated Nov 26, 2019). Affected quantity: 35 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 7, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Nov 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
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
Distribution Pattern
US nationwide distribution
Code Information
Serial Numbers: 40279 10037 1176 40026 1220 40106 40208 40209 40109 40114 40140 40104 40126 40144 10040 10041 40027 40118 40105 40128 40200 40146 10039 40102 40101 40022 40125 40142 40127 40117 40206 1192 1185 40116 40119
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0297-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026