Recall Z-0805-2014— Sorin Group Italia S.r.l.
Class II · Terminated
Class II FDA medical device recall by Sorin Group Italia S.r.l., initiated 2013-11-20, terminated 2014-09-08. FDA's recall record names no specific 510(k) clearance for this event. Product: ORCHESTRA/ORCHESTRA PLUS Programmer. Reason: 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..
- Recalling firm
- Sorin Group Italia S.r.l.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-20
- Terminated
- 2014-09-08
- Firm location
- Saluggia, VC, Italy
Product description
ORCHESTRA/ORCHESTRA PLUS Programmer
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.