Z-3243-2018 Class II Terminated
FDA device recall Z-3243-2018 was initiated by Terumo Cardiovascular Systems Corporation on Aug 28, 2018 and is designated Class II. Reason for recall: Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued… The recall status is terminated (terminated Apr 23, 2020). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2018
- Initiation Date
- Aug 28, 2018
- Termination Date
- Apr 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
Reason for Recall
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
Distribution Pattern
Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
Code Information
Serial Numbers: 1522 1523 1524 1525 1528 1530 1526 1527 1532 1544 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03097 03099 03100 03101 03113 03114 03115 03143 03155 03167 03264
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3243-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026