Mizuho Microsurgical Operating Room Tables Recalled for Unintended Movement
Mizuho America is recalling 10 microsurgical operating room tables due to unintended tilting and infrared signal errors that may cause incorrect operation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of unintended movement during surgery, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Mizuho America, Inc. is recalling 10 units of the Microsurgical Operating Room Tables, model 7300BX (18-351-70). The recall is due to unintended tilting of the tabletop and incorrect operation caused by infrared operating signal errors.
The affected units were distributed in the United States to Arizona, California, Florida, Missouri, North Carolina, Ohio, Pennsylvania, Texas, and Wisconsin, as well as in Greece, Israel, Japan, and Ukraine. Specific serial numbers for the leaking valve issue and the infrared signal errors are listed in the agency's recall documentation.
Healthcare facilities should stop using the affected tables and contact Mizuho America, Inc. for further instructions on the recall and corrective actions.
The recalled product
- Product
- Microsurgical Operating Room Tables;7300BX (18-351-70).
- Manufacturer
- Mizuho America, Inc.
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Tilt Movement-Leaking Valve (7300BX-18-351-70) serial numbers: MUC-20163-0001
- MUC-2016Z-0002
- MUC-2016Z-0003
- MUC-20177-0005
- MUC-20177-0007
- MUC-20177-0008
- MUC-20177-0009
- MUC-20189-0017
- MUC-2018Y-0018 & MUC-2018Y-0019.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mizuho America, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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