Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultra
FDA device recall Z-0864-03 · posted 2003-05-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
- Action taken
- On 3/24/03, the firm issued letters via US Mail to all its direct consignees informing them of the affected device and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAA
- Quantity affected
- 220 units
- Distribution
- Nationwide and worldwide. The product received nationwide distribution to 123 consignees: 23 Distributors (50 transducers) and consumers/users: approximately 100 customers (146 transducers). 2 transdu
- Date initiated
- 2003-03-31
- Date posted
- 2003-05-22
- Date terminated
- 2003-09-22
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON I5100 ULTRASOUND TRANSDUCER (K884632) | Acuson Corp. | 1989-01-13 |