Recall Z-0865-03 ยท MAA Monitor, Fetal Doppler Ultrasound
Siemens Medical Solutions USA, Inc.
Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)
| Date | May 22, 2003 (initiated Mar 31, 2003) |
| Status | Terminated |
| Reason | The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 transducers were consigned to Federal Government locations: (1) Martin Army Community Hospital, 9200 Marne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884632 | ACUSON I5100 ULTRASOUND TRANSDUCER Acuson Corp., Jan 13, 1989 |