Date Initiated by Firm |
January 08, 2019 |
Date Posted |
March 07, 2019 |
Recall Status1 |
Terminated 3 on June 03, 2020 |
Recall Number |
Z-0989-2019 |
Recall Event ID |
82074 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product |
Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A
Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
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Code Information |
Serial Numbers 500001 500002 500003 500004 500005 500006 |
Recalling Firm/ Manufacturer |
GETINGE US SALES LLC 45 Barbour Pond Dr Wayne NJ 07470-2094
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For Additional Information Contact |
Maryanna Krivak 973-709-7483
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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.
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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
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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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