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MONO BACKREST SYSTEM WITH DYNAMIC BACKREST( 2015-08-07)
- Starting date:
- August 7, 2015
- Posting date:
- August 24, 2015
- 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-54788
Affected Products
A. Quickie IRIS with MONO Backrest System with Dynamic Backrest
B. ZIPPIE IRIS WITH MONO BACKREST SYSTEM WITH DYNAMIC BACKREST
Reason
Sunrise Medical (US) LLC recently received two (2) complaints for the Mono Backrest System with the dynamic backrest option on Iris wheelchairs where the back bolts broke and the mono backrest fell backwards. There were no injuries reported in either case.
Affected products
A. Quickie IRIS with MONO Backrest System with Dynamic Backrest
Lot or serial number
IRS-046185 to IRS-063457
IRSE-058994 to IRSE-063928
Model or catalog number
EIZ4-2
Companies
- Manufacturer
-
Sunrise Medical (US) LLC
2842 Business Park Avenue
Fresno
93727
California
UNITED STATES
B. ZIPPIE IRIS WITH MONO BACKREST SYSTEM WITH DYNAMIC BACKREST
Lot or serial number
ZRS-042132 to ZRS-042751
Model or catalog number
EIZ5A
Companies
- Manufacturer
-
Sunrise Medical (US) LLC
2842 Business Park Avenue
Fresno
93727
California
UNITED STATES