U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Massager, Therapeutic, Electric - Product Code ISA
Causa
The housing of the massager's heating applicator attachment may crack during use. if the plastic housing cracks and breaks it could expose the user to live electrical connections and pose a shock hazard.
Acción
In cooperation with Wahl, the Discovery Channel issued a Stop Sales notice on/or about 12/10/2004 throughout its retail chain including fulfillment centers for the website in the U.S.
Wahl sent point of purchase 'Safety Recall Notice' posters to each of the Discovery Channel stores where the massagers were sold. The poster informs the consumer of the electric shock hazard with the heat applicator, illustrates how to determine where the lot number is located on the unit, and instructs the consumer to immediately call customer service at 1-800-767-9245 or visit www.wahl.com or www.shopping.discovery.com to request a free replacement heat applicator. The posters will be posted in the stores and on the Wahl and Discovery websites until 5/1/05.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, Mechanical - Product Code IOR
Causa
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Acción
Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, Mechanical - Product Code IOR
Causa
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Acción
Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, Mechanical - Product Code IOR
Causa
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Acción
Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, Mechanical - Product Code IOR
Causa
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Acción
Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, Mechanical - Product Code IOR
Causa
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Acción
Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pack, Hot Or Cold, Water Circulating - Product Code ILO
Causa
There is the potential that the power switch assembly can dislodge from the cabinet during use.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pack, Hot Or Cold, Water Circulating - Product Code ILO
Causa
There is the potential that the power switch assembly can dislodge from the cabinet during use.
Acción
The firm sent a recall letter by certified mail, dated 1/18/05, to consignees.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat - Product Code IMI
Causa
Device is performing functions that are not cleared in the 510(k).
Acción
The firm initiated the recall procedure 01/05/05. A phone call is made to each facility which has a dermosonic machine. The phone call serves the purpose of telling the customer that their dermosonic machine needs a programming chip replaced, the manual updated and a 'caution' sticker be placed on the machine. An employee of Computer Repair.com then contacts the customer to set up a time to replace the programming chip and manual, and place a 'caution' sticker on the machine.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pack, Hot Or Cold, Water Circulating - Product Code ILO
Causa
There is a possibility of water leaking from the welded seam of the blanket.
Acción
Recall notification was sent out via UPS 2nd day air on 11/22/2004 requesting return of the product and a sub recall if the product was further distributed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Vehicle, Motorized 3-Wheeled - Product Code INI
Causa
Intermittent operation.
Acción
The recalling firm issued a safety alert notification to all dealers/distributors dated 7/04.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Vehicle, Motorized 3-Wheeled - Product Code INI
Causa
Intermittent operation.
Acción
The recalling firm issued a safety alert notification to all dealers/distributors dated 7/04.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, Stair Climbing - Product Code IMK
Causa
Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.
Acción
All individuals/organizations in possession of a device were notified by telephone beginning on August 30, 2004. Letters were mailed to all Customers on 8/31/2004 and to all Clinics on 9/1/2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Component, External, Limb, Ankle/Foot - Product Code ISH
Causa
Braking plates of the 3r90 and 3r92 modular knee joint with friction brake may become dislodged which may cause the braking performance of the knee to malfunction.
Acción
The braking plate of the knee may become dislodged, which may cause the braking performance of the knee to malfunction.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, Stair Climbing - Product Code IMK
Causa
Ibot mobility system may tip over due to malfunction in power base.
Acción
Initial contact to consignees was by telephone on July 2,3,&4 2004. Letters were sent to all consignees from July 5,6,&8, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Component, External, Limb, Ankle/Foot - Product Code ISH
Causa
Flawed shock module might cause breakage causing patient to fall.
Acción
Firm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Chair, Positioning, Electric - Product Code INO
Causa
The heating pad on these lift chairs may tear at the entry point causing a short and/or overheating, which can damage the chair.
Acción
The recalling firm sent a Safety Alert notification to their direct accounts on 5/14/04 informing them of the problem. The direct accounts were instructed to locate the end user and inform them of the problem. Once the chair has been located the direct account is to contact the recalling firm for a replacement and return the recalled chair.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bed, Air Fluidized - Product Code INX
Causa
Battery outgassing of powered hospital beds.
Acción
The firm initiated the recall via letter on 03/22/2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bed, Patient Rotation, Powered - Product Code IKZ
Causa
Battery outgassing of powered hospital beds.
Acción
The firm initiated the recall via letter on 03/22/2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accessories, Wheelchair - Product Code KNO
Causa
Wheelchair seat may not properly support the user due to cracks in the plastic seat base.
Acción
The recalling firm notified dealers by certified letter on 1/19/03. The notification was flagged Attention:Product Recall and advised of seat base susceptibility to cracks and breakage. Dealers were intructed to respond with end user information. Dealers were also provided instructions and materials for crossbar and safety lock installation used with the drop seat bases. Dealers were additionally instructed to forward the provided notification letters to end users.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stretcher, Wheeled, Powered - Product Code INK
Causa
Users may be pinched in the siderail assembly when raising or lowering the siderail.
Acción
Customers were sent a recall letter dated December 30, 2003. The firm will visit each facility and modify the siderail assembly.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, Powered - Product Code ITI
Causa
The weld joints on the seat back may fail and cause possible injury to the patient.
Acción
The firm notified their consignees by letter and telephone on 12/15/2003.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Reports of patient entrapment between mattress and side-rails.
Acción
Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tips For Reducing the Risk of Patient Entrapment.