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Compella Air Supply unit and Therapy Surface (2016-02-26)
- Starting date:
- February 26, 2016
- Posting date:
- March 10, 2016
- 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-57462
Affected Products
- COMPELLA AIR SUPPLY UNIT
- COMPELLA THERAPY SURFACE
Reason
The Compella product has experienced an increase in field complaints regarding pump setpoints and low air loss hose kinking. Electronic control issue of the control unit.
Affected products
-
COMPELLA AIR SUPPLY UNIT
Lot or serial number
- 10
- 11
- 12
- 15
- CX510102
- CX510146
- CX510151
- CX510156
- CX510158
- CX510163
- CX510359
- CX510360
- CX510362
- CX510365
- CX510389
- CX510403
- CX510404
- CY810008
- CY810012
- CY810053
- CZ910090
- CZ910100
- CZ910229
Model or catalog number
P7810
Companies
- Manufacturer
-
Hillrom Corporation
1069 State Route 46 East
Batesville
47006
UNITED STATES
B. COMPELLA THERAPY SURFACE
Lot or serial number
CR600007
CR600063
CR600097
CR600100
CR600105
CR600301
CR600303
CR600304
CR600305
CR600518
CR600520
CR600548
CR600552
CR600563
CR600564
CR600566
CR600568
CR600601
CR600622
Model or catalog number
P642
Companies
- Manufacturer
-
Hillrom Corporation
1069 State Route 46 East
Batesville
47006
UNITED STATES