Z-0864-03

Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the...

Name: Z-0864-03 Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2003-03-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-03-31 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656... on 2003-03-31. The reason FDA records is "The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0864-03
Status: Terminated
Initiated: 2003-03-31
Posted: 2003-05-22
Terminated: 2003-09-22
Recalling firm: Siemens Medical Solutions USA, Inc.
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)
Product code: MAA Monitor, Fetal Doppler Ultrasound
Reason for recall: The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
Root cause tag: software
FDA root 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.
Product codes and lots: All Serial Numbers: XXXXXXXX (8-digit)

Product code MAA

K884632Class IIAcuson I5100 Ultrasound TransducerAcuson Corp. / cleared 1989-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)