175 results
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Sources: EU EUDAMED, US FDA
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Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·April 13, 2022
Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541 Compress Device Centering Sleeve 19mm 178545 Compress Device Centering Sleeve 23mm 178544 Compress Device Centering Sleeve 22mm 178738 Compress Device Centering Sleeve 28mm 178542 Compress Device Centering Sleeve 20mm 32-481123 Compress Instrument Drill For Anti-Rotation Pin 178757 Mini Taper Spindle, 400 lbs, Extra Small 178758 Mini Taper Spindle, 600 lbs, Extra Small 178759 Mini Taper Spindle, 800 lbs, Extra Small 178787 Short Mini Taper Spindle, 400 lbs, Extra Small 178788 Short Mini Taper Spindle, 600 lbs, Extra Small 178789 Short Mini Taper Spindle, 800 lbs, Extra Small
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 26, 2018
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CBK·February 14, 2022
Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541 Compress Device Centering Sleeve 19mm 178545 Compress Device Centering Sleeve 23mm 178544 Compress Device Centering Sleeve 22mm 178738 Compress Device Centering Sleeve 28mm 178542 Compress Device Centering Sleeve 20mm 32-481123 Compress Instrument Drill For Anti-Rotation Pin 178757 Mini Taper Spindle, 400 lbs, Extra Small 178758 Mini Taper Spindle, 600 lbs, Extra Small 178759 Mini Taper Spindle, 800 lbs, Extra Small 178787 Short Mini Taper Spindle, 400 lbs, Extra Small 178788 Short Mini Taper Spindle, 600 lbs, Extra Small 178789 Short Mini Taper Spindle, 800 lbs, Extra Small
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KWA·October 12, 2018
BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; BHM, Magog, Canada, made in China. Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626002C-M Combi Sling Mesh Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626003: Combi Deluxe - Large, capacity 113-272 kg, 250-600 lbs; Part 626003M: Combi Mesh Deluxe - Large, capacity 113-272 kg, 250-600 lbs; and Part 626003X: Combi Oversize Heavy Duty, capacity 113-272 kg, 250-600 lbs. Between 2004 and 2006, the Combi Slings were labeled as BHM Medical Inc. (800) 868-0441, 100% Polyester Shell/100% Nylon Strap, made in Canada. Prior to 2004, the slings were labeled Medi-Man, 100% Polyester Shell, Rehabilitation Products Inc., Mississauga, Ontario, Canada L5T 1X7, made in Canada. The accessory is intended to be used with patient lift for the transfer of patient in hospitals, nursing homes, or other health care facilities by trained caregivers.
FDA Recall
Terminated
·B.H.M. Medical, Inc.·Product code FNG·April 7, 2009
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·January 15, 2014
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
FDA Enforcement
Class II
·Terminated·Advanced Back Technologies, Inc.·June 17, 2015
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
FDA Enforcement
Class II
·Terminated·Advanced Back Technologies, Inc.·June 17, 2015
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
FDA Enforcement
Class II
·Terminated·Handicare Usa Inc·October 18, 2017
Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine Inc.·June 14, 2017
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
FDA Recall
Terminated
·Advanced Back Technologies, Inc.·Product code ITH·May 13, 2015
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
FDA Recall
Terminated
·Advanced Back Technologies, Inc.·Product code ITH·May 13, 2015
Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
FDA Recall
Terminated
·Zimmer Biomet Spine Inc.·Product code LYQ·May 10, 2017
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
FDA Enforcement
Class II
·Terminated·Oakworks Inc·June 15, 2022
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the Volumat MC Agilia infusion pumps. Intended patient population: The Vigilant Drug Lib software must only be used to create drug libraries for patients whose weight is 250g to 250 kg (0.6 lbs. to 551 lbs.).
FDA Enforcement
Class I
·Terminated·Fenwal Inc·August 21, 2019
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
FDA Recall
Terminated
·Handicare Usa Inc·Product code FSA·September 8, 2017
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
FDA Recall
Terminated
·Invacare Corporation·Product code IOR·April 16, 2012
Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), ¿ 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)
FDA Enforcement
Class II
·Terminated·Laerdal Medical Corporation·April 26, 2017
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
FDA Enforcement
Class II
·Terminated·Oakworks Inc·June 15, 2022
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
FDA Recall
Terminated
·Oakworks Inc·Product code FNJ·April 21, 2022