FDA Alerts

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 2003By Kaylee McCaffrey

Date Posted May 22, 2003
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.

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