Class 3 Device Recall Acuson

• Date Initiated by Firm: March 31, 2003
• Date Posted: May 22, 2003
• Recall Status: Terminated on September 22, 2003
• Recall Number: Z-0865-03
• Recall Event ID: 26006
• 510(K)Number: K884632
• Product Classification: Monitor, Fetal Doppler Ultrasound - Product Code MAA
• 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)
• FEI Number: 2936884
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 1230 Shorebire Way; P.O. Box 7393; Mountain View CA 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.
• FDA Determined 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 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MAA