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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet XS Flat Screen Monitor Holder Model number XS32

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  Class 2 Device Recall Maquet XS Flat Screen Monitor Holder Model number XS32 see related information
Date Initiated by Firm January 08, 2019
Date Posted March 07, 2019
Recall Status1 Terminated 3 on June 03, 2020
Recall Number Z-0987-2019
Recall Event ID 82074
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A

Product Usage:
This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Code Information Serial Numbers 500009 500010 500011 500012 500013 500014
Recalling Firm/
Manufacturer		 GETINGE US SALES LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Maryanna Krivak
973-709-7483
Manufacturer Reason
for Recall		 The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.
FDA Determined
Cause 2		 Other
Action Urgent Medical Device Field Correction notification letters dated 1/8/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: -Complete and sign the enclosed Customer Response Form (Pages 4 and 5) and return to Getinge using the fax number or email address provided on the form. -A Getinge Service person will contact the person listed on the Customer Response Form (page 5) to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getinge-trained or authorized service technician by calling Getinge Customer Support at (800) 950-9912 (select option 1).
Quantity in Commerce 6
Distribution The products were distributed to the following US states: AZ and TX.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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