IE33 Diagnostic Ultrasound System-Sector Transducer and EPIQ Ultrasound Transducers (2019-09-06)
- Starting date:
- September 6, 2019
- Posting date:
- September 20, 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-71017
Last updated: 2019-09-20
Affected Products
- IE33 Diagnostic Ultrasound System-Sector Transducer
- EPIQ Ultrasound Transducers
Reason
A small number of S7-3T and S8-3T TEE transducers were not properly programmed during manufacturing, as a result the system is unable to correctly measure the temperature on the distal tip of the transducer. EPIQ and IE33 systems will show the transducer temperature (TEE T) as
0.0°c>
Affected products
-
IE33 Diagnostic Ultrasound System-Sector Transducer
Lot or serial number
Not applicable.
Model or catalog number
S8-3T
Companies
- Manufacturer
-
Philips Ultrasound Inc.
22100 Bothell-Everett Highway
Bothell
98021-8431
Washington
UNITED STATES
B. EPIQ Ultrasound Transducers
Lot or serial number
Not applicable.
Model or catalog number
S7-3T
S8-3T
Companies
- Manufacturer
-
Philips Ultrasound Inc.
22100 Bothell-Everett Highway
Bothell
98021-8431
Washington
UNITED STATES