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Orchestra and Orchestra Plus Programmers (2013-11-21)
- Starting date:
- November 21, 2013
- Posting date:
- January 6, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37279
Recalled products
- Orchestra Plus Programmers
- Orchestra Programmer
Reason
Sorin is notifying users of the overestimation of residual longevity displayed by Orchestra and Orchestra Plus programmers during follow-up exams of patients implanted with reply and esprit rate responsive pacemakers. Because of the incorrect information, the follow-up dates might not have been adjusted when nearing the ERI (Elective Replacement Indicator). When the device approaches the ERI, this overestimation could result in ERI or EOL (End of Life) being reached between two follow-up visits.
Affected products
A. Orchestra Plus Programmers
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- Orchestra Plus
Companies
- Manufacturer
-
Sorin Group Italia S.R.L. (Sorin CRM)
Via Crescentino S.N.
Saluggia, Vercelli
13040
ITALY
B. Orchestra Programmer
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- Orchestra
Companies
- Manufacturer
-
Sorin Group Italia S.R.L. (Sorin CRM)
Via Crescentino S.N.
Saluggia, Vercelli
13040
ITALY