Terminated

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 Recall Z-0865-03 · Posted 2003-05-22

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeMAA

Date Initiated2003-03-31

Date Terminated2003-09-22

Product Quantity220 units

Reason for Recall

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

Firm 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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K884632ACUSON I5100 ULTRASOUND TRANSDUCERAcuson Corp. · 1989-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.