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Devices
Device Recall BodyGuard
Model / Serial
All product with USA36A4.4 version of software affected
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.
Product Description
BodyGuard 323 pump, models || 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, || 100-603XSA and 100-603XSAP
Manufacturer
CME America, LLC
1 Event
Recall of Device Recall BodyGuard
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Manufacturer
CME America, LLC
Manufacturer Address
CME America, LLC, 14998 W 6th Ave, Golden CO 80401-6587
Manufacturer Parent Company (2017)
CME America, LLC
Source
USFDA
Language
English
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