253 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPACELABS HEALTHCARE LTD.
FDA registration
SPACELABS HEALTHCARE LTD.·10 products·🇬🇧 United Kingdom
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
FDA Recall
Terminated
·Spacelabs Healthcare Inc·Product code DXH·September 3, 2015
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
FDA Recall
Terminated
·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code BSZ·October 17, 2013
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
FDA Enforcement
Class I
·Terminated·Del Mar Reynolds Medical, Ltd.·November 27, 2013
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·October 14, 2016
BLEASESIRIUS ANAESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·July 21, 2015
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·August 5, 2015
BLEASESIRIUS ANAESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·September 18, 2015
SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF
FDA Adverse Event
Injury
·SPACELABS HEALTHCARE LTD.·Product code DXN·September 18, 2015
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·August 17, 2015
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·September 18, 2015
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·September 21, 2015
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·September 21, 2015
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·September 19, 2015
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·September 18, 2015
BLEASESIRIUS ANAESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code CBK·September 18, 2015
BLEASESIRIUS ANAESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code BSZ·March 27, 2012
BLEASESIRIUS ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE, LTD.·Product code BSZ·June 20, 2014
BLEASESIRIUS ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code BSZ·June 23, 2010
BLEASESIRIUS ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD·Product code BSZ·June 25, 2010