Health product recall

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