ORCHESTRA/ORCHESTRA PLUS Programmer
Reported: January 29, 2014 Initiated: November 20, 2013 #Z-0805-2014
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.
Details
- Recalling Firm
- Sorin Group Italia S.r.l.
- Units Affected
- 1,718
- Distribution
- Nationwide.
- Location
- Saluggia, VC
Frequently Asked Questions
What product was recalled? ▼
ORCHESTRA/ORCHESTRA PLUS Programmer. Recalled by Sorin Group Italia S.r.l.. Units affected: 1,718.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2014. Severity: Moderate. Recall number: Z-0805-2014.
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