4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816,
FDA device recall Z-2149-2011 · posted 2011-05-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.
- Action taken
- A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Quantity affected
- 42 units
- Distribution
- Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece.
- Date initiated
- 2009-07-10
- Date posted
- 2011-05-05
- Date terminated
- 2011-05-05
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM (K072365) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-10-17 |