Recall Z-0990-2019— GETINGE US SALES LLC
Class II · Terminated
Class II FDA medical device recall by GETINGE US SALES LLC, initiated 2019-01-08, terminated 2020-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.. Reason: 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..
- Recalling firm
- GETINGE US SALES LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-08
- Terminated
- 2020-06-03
- Firm location
- Wayne, NJ, United States
Product description
Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.