Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
FDA device recall Z-1750-2013 · posted 2013-07-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
- Action taken
- Siemens sent an Urgent Customer Information letter to their consignees. The letter identified the affected product, problem , update Instructions and actions to be taken. Siemens began to equip affected systems with a modified board assembly in January, 2013.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 23
- Distribution
- United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.
- Date initiated
- 2013-01-31
- Date posted
- 2013-07-17
- Date terminated
- 2014-11-12
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE / ZEEGOS WITH SW VC14 (K090745) | Siemens Medical Solutions USA, Inc. | 2009-06-18 |