87 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
FDA Recall
Terminated
·Lifeline Systems Company·Product code ILQ·November 13, 2017
MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.
FDA Recall
Terminated
·Medminder Systems, Inc.·Product code ILQ·March 28, 2022
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
FDA Recall
Terminated
·Stanley Security Solutions Inc·Product code ILQ·June 22, 2016
Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.
FDA Recall
Terminated
·Philips Lifeline Inc·Product code ILQ·September 11, 2009
P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
FDA Recall
Terminated
·Tobii Assistive Technology, Inc.·Product code ILQ·January 14, 2013
Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers
FDA Recall
Terminated
·Rauland-Borg Corp·Product code ILQ·May 10, 2013
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code ILQ·April 13, 2022
Dynavox T10 Speech Generating Device ( including Batteries)
FDA Recall
Terminated
·Dynavox Systems Llc·Product code ILQ·December 14, 2017
Philips GoSafe Communicator 7000L Personal emergency response system.
FDA Recall
Terminated
·Lifeline Systems, Incorporated·Product code ILQ·April 22, 2015
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
FDA Recall
Terminated
·Lifeline Systems, Incorporated·Product code ILQ·July 23, 2015
Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices. Communication device for the impaired and functions as a speech generating device; text or symbols can be used to generate synthesized or digitized speech. Perfect for asking or answering questions, having a conversation.
FDA Recall
Terminated
·Tobii Assistive Technology, Inc.·Product code ILQ·May 31, 2011
Dynavox T15 Speech Generating Device ( including Batteries)
FDA Recall
Terminated
·Dynavox Systems Llc·Product code ILQ·December 14, 2017
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020
FDA Recall
Terminated
·Hill-Rom Inc.·Product code ILQ·October 14, 2021
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code ILQ·April 13, 2022
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·July 2, 2014
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·October 31, 2018
ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Renown Lemon Disinfectant Deodorant, Distributed by AmSan, LLC, Deerfield, IL; (2) Concept Lemon Scented Disinfectant Deodorant, Product 5282057750, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA.
FDA Recall
Terminated
·ITW Dymon·February 15, 2005
ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 108" X 77" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TIME OUT BEACON NON WOVEN (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) POLISHER CAUTERY TIP (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLIBLADE 20C FOAM/MAG (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP AAMI LEVEL Il (1) BAG GLASSINE PLAIN (1) ELECTRODE DUAL DEPRES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014
ITW Dymon Medaphene Plus Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product 34720. The firm name on the label is ITW Dymon, Olathe, KS. The product is also sold under the following private labels: (1) Renown Disinfectant Deodorant II, Product REN05013, Distributed by AmSan, LLC, Deerfield, IL; (2) Decon Aerosol Disinfectant, Catalog #8617, Manufactured For Decon Labs, Inc., Bryn Mawr, PA; (3) New Jax Medaphene Plus Disinfectant Spray, Sold By Newell Paper Company, Hattiesburg, MS, Columbus, MS, Meridian, MS; (4) San-O-Phene Plus Disinfectant Spray, Sold By San Joaquin Supply Co., Fresno, CA; (5) Sterling Quality Hospital Use Micro II Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (6) Ball-Phene Spray Disinfectant, Reorder #3U037, Manufactured for W.W. Grainger, Inc., Lake Forest, IL; (7) Area Two-In-One Disinfectant Spray Original, Sold By Area Distributors, Inc., Quincy, IL; (8) Benefax Disinfectant Spray, Exclusively Sold By Biotek Corporation, Melrose Park, IL; (9) Pheno-Cen Spray Disinfectant/Deodorant, Sold By Central Solutions, Inc., Kansas City, KS; (10) Clark Bio-Phene Plus Disinfectant/Spray, Sold By Clark Paper Plus Inc., Carteret, NJ; (11) LOGIChem Hosp-I-Septic Disinfectant Spray, Distributed Exclusively For Edmar, Woodside, NY; (12) Morcept Hospital Disinfectant, Sold By Moore Research, Inc., St. Louis, MO; (13) Pro Chem Deocept Purity Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (14) Select Specialty Products Spectrum II Hospital Type Disinfectant, Sold By Select Specialty Products, Charlottesville, VA.
FDA Recall
Terminated
·ITW Dymon·Product code LRJ·February 15, 2005
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Recall
Terminated
·Data Innovations, LLC·Product code JQP·August 29, 2018