Mizuho CE IPX4 recall
Mizuho 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…
Why was Mizuho CE IPX4 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Mizuho 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…
- Recalling firm
- Mizuho OSI
- Quantity
- 26 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.
- Recall date
- March 31, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)