Orchestra/orchestra Plus Programmer recall
ORCHESTRA/ORCHESTRA PLUS Programmer
Why was Orchestra/orchestra Plus Programmer recalled?
Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR - ESPRIT Models D, DR, S, SR - FACIL Model DR1
- Product
- ORCHESTRA/ORCHESTRA PLUS Programmer
- Recalling firm
- Sorin Group Italia S.r.l.
- Quantity
- 1,718
- Distribution
- Nationwide.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)