PRISMAFLEX Hemodialysis Unit, PRISMAFLEX with Software release 4.00, 5.00, 6.10, 7.10, 8.10 (2018-05-03)
- Starting date:
- May 3, 2018
- Posting date:
- June 1, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66920
Affected products
A. PRISMAFLEX HEMODIALYSIS UNIT
B. PRISMAFLEX WITH SOFTWARE RELEASE 4.00
C. PRISMAFLEX WITH SOFTWARE 5.00
D. PRISMAFLEX WITH SOFTWARE 6.10
E. PRISMAFLEX WITH SOFTWARE 7.10
F. PRISMAFLEX WITH SOFTWARE 8.10
Reason
Baxter corporation will be installing new firmware on all PRISMAFLEX Control Units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics, which may result in a "voltage out of range" malfunction alarm.
Affected products
A. PRISMAFLEX HEMODIALYSIS UNIT
Lot or serial number
All serial numbers.
Model or catalog number
107493-6023014700
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
B. PRISMAFLEX WITH SOFTWARE RELEASE 4.00
Lot or serial number
All serial numbers.
Model or catalog number
113082
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
C. PRISMAFLEX WITH SOFTWARE 5.00
Lot or serial number
All serial numbers.
Model or catalog number
113874
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
D. PRISMAFLEX WITH SOFTWARE 6.10
Lot or serial number
All serial numbers.
Model or catalog number
114489
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
E. PRISMAFLEX WITH SOFTWARE 7.10
Lot or serial number
All serial numbers.
Model or catalog number
114870
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
F. PRISMAFLEX WITH SOFTWARE 8.10
Lot or serial number
All serial numbers.
Model or catalog number
955052
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN