Class 3 Recall: Acuson
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
Thu May 22 2003
Date Posted | May 22, 2003 |
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Recall Status1 | Open |
Recall Number | Z-0865-03 |
Recall Event ID | 26006 |
Product | 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) |
Code Information | All Serial Numbers: XXXXXXXX (8-digit) |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 1230 Shorebire Way P.O. Box 7393 Mountain View, California 94039-7393 |
Manufacturer Reason for Recall |
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit. |
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 in Commerce | 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 Rd., Fort Benning, GA 31905, (2) Lackland AFB, Wilford Hall, 2200 Bergquist Dr., #100, Lackland AFB, TX 78236. The firm has also distributed product into international channels through distributors. Countries include, Austria; Barbados; Brazil; Canada; China (PRC); Egypt, France, Germany; Greece; India; Italy; Japan; South Korea; Netherlands; Russia; Saudi Arabia; Sweden; Taiwan; and United Kingdom. There is no Canadian distribution. The firm is continuing to obtain the international distribution through the distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, and users who received the recalled product. |