5 results
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29ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
FDA Recall
Terminated
·iwalk inc·Product code ISW·October 26, 2012
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
FDA Enforcement
Class II
·Terminated·iwalk inc·December 12, 2012
ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers. W1801R-Red, UPC 7 54756 91803 3 all serial numbers. The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles. Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds. Warranty Card: "...lifetime of the original purchaser...". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser.
FDA Recall
Terminated
·Essential Medical Supply, Inc.·Product code ITJ·December 21, 2009
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LTT·March 6, 2013
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
FDA Recall
Terminated
·Carestream Health Inc·Product code IZL·November 25, 2014