Z-0988-2014Class II

Siemens Prisma 2K Hearing Aid

Name: Z-0988-2014 Siemens Prisma 2K Hearing Aid
Creator: Siemens Hearing Instruments, Inc
Published: 2005-07-01
License: https://open.fda.gov/license/

Siemens Hearing Instruments, Inc. / initiated 2005-07-01 / Terminated / root cause: design

FDA source

Siemens Hearing Instruments, Inc began a recall of Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients on 2005-07-01. FDA classified it as Class II and gives the reason as "Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0988-2014
Classification: Class II
Status: Terminated
Initiated: 2005-07-01
Posted: 2014-02-18
Terminated: 2017-07-06
Recalling firm: Siemens Hearing Instruments, Inc.
Product: Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Product code: LEZ Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Reason for recall: Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent a notice letter to affected customers in 7/2005 and 12/2005. The letter identified the affected product, problem and actions to be taken. Siemens will install an additional security measure to affected product at no charge. For questions contact your Sales Representative at 800-766-4500.
Quantity in commerce: 738 units
Distribution: USA Nationwide Distribution
Product codes and lots: Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0988-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0988-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-18

Product code LEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)