Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, Part No: 54 96 984; Siemens Me
FDA device recall Z-0283-2008 · posted 2008-01-31 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
- Action taken
- Customers were sent a Customer Safety Advisory Notice on February 27, 2007, notifying them that the mounting screws on the cassette holders on the SIMVIEW 3000 and NT Simulators, as well as some MEVASIM Simulators, could loosen and can cause damage to the system, or personal injury. The firm requested that they check of tightness on the mounting hardware. A STOP Modification notice was issued on 06/01/2007, to all affected regional service organizations that are responsible for implementing updates due to new information. Updated letters and User instructions will be released in August 2007.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- KPQ
- Quantity affected
- 287 units total, all recalls Z-0281-285-2008
- Distribution
- Worldwide Distribution - USA including states of IN, VA, MA, VT, NJ, NY, PA, DC, NC, SC, GA, AL, TN, MI, KY, OH, IN MI, MN, ND, MT, IL, MO, KS, NE, AR, OK, TX, AZ, CA, SD, LA, Puerto Rico, and countri
- Date initiated
- 2007-02-27
- Date posted
- 2008-01-31
- Date terminated
- 2011-02-03
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIMVIEW(TM) 3000 (K946053) | Siemens Medical Solutions USA, Inc. | 1995-03-31 |