FDAFDA · Food and drugs·Recall number Z-0805-2014
ORCHESTRA/ORCHESTRA PLUS Programmer
Published January 29, 2014 · Recall initiated: November 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sorin Group Italia S.r.l.
- Distributor
- Nationwide.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.