ITS4850A IntelliVue Telemetry System - MONITOR (2018-11-11)
- Starting date:
- November 11, 2018
- Posting date:
- November 28, 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-68424
Affected products
ITS4850A IntelliVue Telemetry System - MONITOR
Reason
The volume of the MX40 speaker in these devices may be diminished or not audible above 4,500 feet when operating in monitor mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the power on self-test.
Affected products
ITS4850A IntelliVue Telemetry System - MONITOR
Lot or serial number
Not applicable
Model or catalog number
- MX40
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
UNITED STATES