Magnetom Allegra System. Nuclear Magnetic Resonance Imaging Diagnostic Device
FDA device recall Z-0522-04 · posted 2004-02-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- tissue roll can become magnetic
- Action taken
- The recalling firm has issued Updated Instructions to replace the stainless steel tissue roll holder. The recalling firm''s representatives are visiting each account to replace the tissue roll holder.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 16 units
- Distribution
- The product was shipped to medical facilities in CA, CT, DC, FL, GA, IL, IN, KS, KY, MA, MD, MN, NC, NY, OH, OR, PA, TX, and UT.
- Date initiated
- 2003-12-18
- Date posted
- 2004-02-10
- Date terminated
- 2004-11-09
- 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 |
|---|---|---|
| MAGNETOM ALLEGRA SYSTEM (K002179) | Siemens Medical Solutions USA, Inc. | 2000-10-11 |