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Class 3 Device Recall Acuson |
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Date Initiated by Firm |
March 31, 2003 |
Date Posted |
May 22, 2003 |
Recall Status1 |
Terminated 3 on September 22, 2003 |
Recall Number |
Z-0864-03 |
Recall Event ID |
26006 |
510(K)Number |
K884632
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Product Classification |
Monitor, Fetal Doppler Ultrasound - Product Code MAA
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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)
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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 CA 94039-7393
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Manufacturer Reason for Recall |
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = MAA and Original Applicant = ACUSON CORP.
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