Oscar 2, ABP/CBP System (2020-03-31)
- Starting date:
- March 31, 2020
- Posting date:
- May 8, 2020
- 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-73015
Last updated: 2020-05-08
Affected Products
- Oscar 2, ABP System
- Oscar 2, ABP/CBP System
Reason
Suntech Medical Instruments, Inc. received a complaint (COM-000123) stating that the unit displayed 12.0 Instead on 120. Investigation has revealed that an erroneous configuration setting was applied to the devices during production.
Affected products
A. Oscar 2, ABP System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 99-0133-00
- 99-0133-01
Companies
- Manufacturer
-
Suntech Medical Inc.
507 Airport Blvd., Suite 117
Morrisville
27560
North Carolina
UNITED STATES
B. Oscar 2, ABP/CBP System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 99-0133-02
- 99-0133-03
Companies
- Manufacturer
-
Suntech Medical Inc.
507 Airport Blvd., Suite 117
Morrisville
27560
North Carolina
UNITED STATES