MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Mult
FDA device recall Z-1505-2014 · posted 2014-04-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be afixed with transversal carriage, with Loctite 243 and Torque 10nm during system installation. Siemens initiated the update instruction to verify and secure the hose holder with Loctite 243. A PCB D802 Rev. 00 b
- Action taken
- Affected customers were initially notified with a recall letter on/about 2/12/14 and were sent Update Instructions to affected customers.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 12
- Distribution
- Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.
- Date initiated
- 2014-02-13
- Date posted
- 2014-04-24
- Date terminated
- 2015-03-16
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIX FUSION (K121513) | Siemens Medical Solution | 2012-08-10 |