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System 1, Roll Pump Pods (2015-05-26)
- Starting date:
- May 26, 2015
- Posting date:
- July 7, 2015
- 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-54008
Recalled Product
A. System 1, Roll Pump Pods
Reason
This notice is to inform the end user of the potential need for replacement (market withdrawal) that could occur during the software upgrade. Terumo CVS identified a small number of printed circuit boards used in the Terumo system 1 roller pump assembly that were produced and distributed that contained an EEPROM chip that does not support a software upgrade.
Affected products
A. System 1, Roll Pump Pods
Lot or serial number
- 0013
- 0021
- 0144
- 0146
- 1177
Model or catalog number
- 801763
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
Michigan
UNITED STATES