—#26858

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)

FDA product code: MAA — Monitor, Fetal Doppler Ultrasound
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K884632
Affected lot / code info: All Serial Numbers: XXXXXXXX (8-digit)

Why it was recalled

The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebire Way P.O. Box 7393, Mountain View, California 94039-7393

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2003-03-31
Posted by FDA: 2003-05-22
Terminated: 2003-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.