Norm-O-Temp Hyperthermia System (2019-07-18)
- Starting date:
- July 18, 2019
- Posting date:
- August 9, 2019
- 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-70643
Last updated: 2019-08-09
Affected Products
Norm-O-Temp Hyperthermia System
Reason
The Norm-O-Temp manual does not provide instruction stating that exceeding 40°C for extended periods can cause tissue damage.
Affected products
Norm-O-Temp Hyperthermia System
Lot or serial number
113-0001N - 193-0824N
Model or catalog number
111Z
Companies
- Manufacturer
-
Cincinnati Sub-Zero Products
12011 Mosteller Road
Cincinnati
Ohio
UNITED STATES