FDA Enforcement
Class II
Ongoing
Microsurgical Operating Room Tables;7300B (18-350-70);
Recall: Z-0566-2021
·
Reported December 23, 2020
Enforcement
- Recall Number
- Z-0566-2021
- Event ID
- 85442
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mizuho America, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- December 23, 2020
- Initiation Date
- September 11, 2019
- Classification Date
- December 14, 2020
- Address
- 30057 Ahern Ave, N/A, Union City, CA, 94587-1234, United States
Description
Microsurgical Operating Room Tables;7300B (18-350-70);
Reason
Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.
Code Info
MUC-20168-0001, MUC-20168-0002, MUC-20171-0003, MUC-20171-0004, MUC-20173-0005, MUC-20173-0006, MUC-20178-0007 & MUC-20178-0008
Distribution
US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.
Quantity
8