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.
Notas adicionales en la data
Stretcher, Wheeled, Powered - Product Code INK
Causa
The user may be pinched by the siderail when raising or lowering the siderail.
Acción
Recall letters dated 12/1/03 were sent to each consignee notifying them that Stryker would be contacting them to 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.
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.
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.
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
Power cord overheating.
Acción
Consignees were notified by letter sent January 14, 2002 warning them of the hazard involved with the defective part. They were informed that Hill Rom needed to replace the power cord on each unit to correct the possibility of the power cord from overheating, melting or smoking. The maintenance would be performed at the location of each unit (most of which are at their rental facilities located nationwide) by the firm''s servicing representatives. Meanwhile, customers were urged to check the power cord to ensure that it is fully inserted into the wall outlet and the connector on the Clinitron At Home Air Fluidized Therapy Unit. The modification was to be completed by August 31, 2002.
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
Table, Mechanical - Product Code INW
Causa
Product contains an improper bracket for the transducer.
Acción
Recall notification was initiated by telephone on 05/30/2003 to the domestic accounts and via email to the foreign accounts.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
unknown device name - Product Code ITF
Causa
Product contains an improper bracket for the transducer.
Acción
Notification of the manufacturing defect and recall was initiated by telephone on 05/30/2003 to the domestic accounts and via email to the foreign accounts.
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
unknown device name - Product Code : IPM
Causa
Product may not be sterile.
Acción
Distributor was notified via email on 6/11/2003 and advised to quarantine the product. A follow up letter was sent via certified mail to the distributor and to the contract packer on 6/18/2003 with a questionnaire and a self addressed stamped envelope to verify effectiveness.
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
Malfunction of side-rail latching pin coupled with inadequate directions for use.
Acción
Consignees were notified by letter sent via Airborne express, on May 5, 2003. Side-rail latching pins will be replaced with a more robust version. Label indicating directions for use will be modified to include detailed information on proper procedures for moving the units.
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
Malfunction of side-rail latching pin coupled with inadequate directions for use.
Acción
Consignees were notified by letter sent via Airborne express, on May 5, 2003. Side-rail latching pins will be replaced with a more robust version. Label indicating directions for use will be modified to include detailed information on proper procedures for moving the units.
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
Vehicle, Motorized 3-Wheeled - Product Code INI
Causa
The plastic tires may shatter if the tire is over-inflated and could cause serious injury.
Acción
All consignees were notified via personalized recall letter on 2/7/2003. The firm also posted the notice on their website on 2/14/2003. Customers will be asked to send back order form for new metal wheel tires.
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
Stitching in wheelchair seat back is defective and may not support user.
Acción
Firm notified dealers and sales representatives by certified letter on 2/25/03. Dealers were requested to phone the company for replacement options. Sales representatives were advised of the stitching failure via an 'urgent product recall' letter and instructed to immediately cease use and distribution, and further notify customers. Reps were asked to collect all recalled parts WPHS from consignees they have identified and return with response form.
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
One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.
Acción
Permobil Inc has notified its field representatives of the voluntary recall and these representatives have been provided with lists of each Chairman 2K serial number and the Dealer to which the wheelchair was sold. This list also includes the name of the individual for whom the wheelchair was specified at the time of order from Permobil Inc, where applicable.
The Permobil field representatives have been trained to perform the upgrade and have been provided the necessary tools to complete the task. They will also train and supervise the Dealer''s technicians who will effect the upgrade at the Dealer level, as the field representatives will rely upon their Dealer network to complete the upgrades in a timely fashion.
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
A short circuit within the charger harness may cause heat damage to the units with potential for fire.
Acción
On 3/10/2003, the firm mailed recall letters to all affected dealer accounts. The dealers were asked to contact all customers who have purchased powered wheelchairs with the optional Tarsys Seating System.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
unknown device name - Product Code I--TI
Causa
Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.
Acción
Permobil Inc has notified its field representatives of the voluntary recall and these representatives have been provided with lists of each Chairman 2K serial number and the Dealer to which the wheelchair was sold.
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
Joint, Knee, External Brace - Product Code ITQ
Causa
Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
Acción
The firm notified its consignees by letter dated 2/19/2003 asking them to return any in-stock product and to contact their consignees 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
Wheelchair, Powered - Product Code ITI
Causa
A short circuit within the charger harness may cause heat damage to the units with potential for fire.
Acción
On 3/10/2003, the firm mailed recall letters to all affected dealer accounts. The dealers were asked to contact all customers who have purchased the scooters.
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
The plastic tires may shatter if the tire is over-inflated and could cause serious injury.
Acción
All consignees were notified via personalized recall letter on 2/7/2003. The firm also posted the notice on their website on 2/14/2003. Customers will be asked to send back order form for new metal wheel tires.
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 out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
Acción
In approximately November 1997 the firm implemented the TransportAir retrograde for all active units.
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 component is defective.
Acción
Firm notified customers by certified letter 5/14/02 and advised of potential for serious injury. Letter instructs customers to cease use and distribution of any defective hooks and return for replacement. Firm additonally instructed dealers to notify end-users about the recall.
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
Bandage, cast - Product Code ITG
Causa
A quarantined lot of the devices was released for sale. devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
Acción
On 8/18/17, the recalling firm's sales reps notified affected consignees of the recall and distributed customer letters. Customers were asked to examine their inventory for product from the affected lot, warned not to use the product, complete the included "Acknowledgement and Return Form", and return the form by email or fax. Customers were provided with a Customer Service number: 1-800-654-2873.
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
System, communication, powered - Product Code ILQ
Causa
The battery is integral to the device. if the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. the battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. this battery may cause the device case to separate a small amount.
Acción
On February 26, 2018 an URGENT MEDICAL RECALL LETTER was issued to customers with the subject line listing the serial number specific to that customer along with the date of purchase. The letter informs customers of the issue and instructs customers to return product to one of their facilities to have the product repaired until an RA. Questions or concerns can be directed to 1-800-344-1778, Press 1 and then Press 2.
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
System, communication, powered - Product Code ILQ
Causa
The battery is integral to the device. if the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. the battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. this battery may cause the device case to separate a small amount.
Acción
On February 26, 2018 an URGENT MEDICAL RECALL LETTER was issued to customers with the subject line listing the serial number specific to that customer along with the date of purchase. The letter informs customers of the issue and instructs customers to return product to one of their facilities to have the product repaired until an RA. Questions or concerns can be directed to 1-800-344-1778, Press 1 and then Press 2.
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
System, communication, powered - Product Code ILQ
Causa
A programing error in some model fd100 homesafe autoalert pendants will render the fall detection feature
inoperable.
Acción
Firm has contacted all recipients and informed them of an issue that affects Philips Lifeline AutoAlert help button from automatically signaling the Lifeline Response Center for help in the event of a fall. Further instructed them that they would need to press the Lifeline Help Button in order to connect with the emergency response center. They then instruct them to return their inventory for replacement. New AAHB Replacements will be provided when available. Philips will work with the Programs to ensure buttons swaps are completed.