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U.S. Department of Health and Human Services

Class 2 Device Recall Mizuho Electrohydraulic Operating Table

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 Class 2 Device Recall Mizuho Electrohydraulic Operating Tablesee related information
Date Initiated by FirmFebruary 08, 2021
Create DateMarch 23, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1293-2021
Recall Event ID 87318
Product Classification Table, operating-room, electrical - Product Code GDC
ProductMizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
Code Information S/N (Control unit) - S/N (Operating table): 10290134 - MEC-20195-0034, 10290135 - MEC-20195-0036, 10290136 - MEC-20195-0035, 10290137 - MEC-20195-0033, 10490143 - MEC-20198-0038, 10490144 - MEC-20198-0037, 10490145 - MEC-20198-0040, 10490147 - MEC-20198-0039, 10690148 - MEC-2019Y-0054, 10690149 - MEC-20199-0049, 10690150 - MEC-2019Y-0059, 10690153 - MEC-2019Y-0058, 10690154 - MEC-20199-0046, 10690155 - MEC-2019Y-0057, 10690156 - MEC-20199-0050, 10690157 - MEC-20199-0044, 10690159 - MEC-20199-0047, 10690160 - MEC-20199-0051, 10690161 - MEC-20199-0045, 10690162 - MEC-20199-0048, 10690163 - MEC-2019Y-0053, 10790167 - MEC-2019Y-0052, 10790169 - MEC-2019Y-0056, 10790170 - MEC-2019Y-0055, 211080129 - MEC-2018Z-0029, 11080130 - MEC-2018Z-0028
FEI Number 2921578
Recalling Firm/
Manufacturer		 Mizuho OSI
30031 Ahern Ave
Union City CA 94587-1234
For Additional Information ContactAnne LeBlanc
510-429-1500 Ext. 128
Manufacturer Reason
for Recall		There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 2/3/2021 Mizuho sent a "Recall Notice for Control Unit" notification letter to affected consignees via Email. In addition to informing consignees about the recall the notification asked consignees to take the following actions: 1. Identify if you have the affected product, 2. Mizuho will replace control units. As soon as we are ready for your institutions, Mizuho will supply the replacements. Please use the auxiliary switch on the operating table until the replacements arrive.
Quantity in Commerce26 units
DistributionWorldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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