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U.S. Department of Health and Human Services

Class 2 Device Recall OPMI LUMERA 300

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 Class 2 Device Recall OPMI LUMERA 300see related information
Date Initiated by FirmAugust 18, 2023
Date PostedOctober 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0183-2024
Recall Event ID 93146
Product Classification Microscope, surgical, general & plastic surgery - Product Code FSO
ProductOPMI LUMERA 300, REF 6137
Code Information UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
FEI Number 3008564898
Recalling Firm/
Manufacturer		 Carl Zeiss Suzhou Co., Ltd.
Modern Industrial Square 3b
No. 333 Xingpu Road; Kunshan
Suzhou China
Manufacturer Reason
for Recall		Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.
FDA Determined
Cause 2		Process control
ActionOn 8/18/23, correction notices were mailed to customers who were asked to do the following: Before each use of the affected device, perform the following mandatory inspection: Refer to pictures in the notice showing a gap between the OPMI and the inspection arm. This gap should not be greater than 5mm. If the gap is greater than 5mm, please Immediately stop using the device! In this case the affected device can no longer be used. The firm is planning to inspect (repair if needed) the suspension arm immediately. Service staff will contact you to arrange an appointment for inspection (repair if needed) of the suspension arm. Complete and return the acknowledgement and receipt form and return to USFCA.meditec.us@zeiss.com If you have any questions, contact firm Customer Support at 877-486-7473.
Quantity in Commerce8
DistributionUS Nationwide distribution in the states of MD, TX, CA, GA, LA.
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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