Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography s
FDA device recall Z-0972-2015 · posted 2015-01-14 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.
- Action taken
- Siemens sent an important customer safety information notice, dated December 3, 2014, to all affected customers. The letter identified the product, problem, and action to be taken. The following hardware modifications will be implemented with the corrective action AX042/14/S: 1. A modified cable outlet to provide additional space for the cabling. 2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area of the arc. In general all systems will be checked for existing damage prior to the implementation of this action. For questions regarding this recall call 610-219-6300.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 50
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-12-03
- Date posted
- 2015-01-14
- Date terminated
- 2015-04-06
- 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 |
|---|---|---|
| ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM (K123529) | Siemens Medical Solutions USA, Inc. | 2013-02-26 |