Class 2 Device Recall Siemens Hearing Instruments Inc.

• Date Initiated by Firm: July 01, 2005
• Date Posted: February 18, 2014
• Recall Status: Terminated on July 06, 2017
• Recall Number: Z-0988-2014
• Recall Event ID: 67241
• Product Classification: Aids, speech training for the hearing impaired (ac-powered and patient-contact) - Product Code LEZ
• Product: Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
• Code Information: Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
• Recalling Firm/ Manufacturer: Siemens Hearing Instruments, Inc; 10 Constitution Ave; Piscataway NJ 08855
• For Additional Information Contact: Mr. John Schirado; 732-562-6600
• Manufacturer 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.
• FDA Determined 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
• 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.