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LIFEPAK CR Express and Plus (2016-09-16)
- Starting date:
- September 16, 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-60582
Affected Products
- LIFEPAK CR Express (Semi-Automatic Operation)
- LIFEPAK CR Plus (Semi-Automatic)
- LIFEPAK CR Plus (Fully Automatic)
Reason
Physio-Control has become aware of an issue whereby the LIFEPAK CR Plus AED or LIFEPAK Express AED may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. Physio-Control has determined that there are presently 25,178 devices in the field, of which approximately 9,600 may have this faulty component. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. All reports received from customers have been noted during initial set up and testing of the device.
Affected products
A. LIFEPAK CR Express (Semi-Automatic Operation)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 80427-000155
- 80427-000156
- 99427-000129
- 99427-000133
Companies
- Manufacturer
-
Physio-Control Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES
B. LIFEPAK CR Plus (Semi-Automatic)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3200731-XXX
3202359-019
3202359-092
3202359-XXX
80403-000278
80403-000280
99403-000156
99403-000209
Companies
- Manufacturer
-
Physio-Control Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES
C. LIFEPAK CR Plus (Fully Automatic)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3200731-XXX
3202359-XXX
80403-000279
80403-000281
99403-000157
99403-000210
Companies
- Manufacturer
-
Physio-Control Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES