4 results
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10ms
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Sources: EU EUDAMED, US FDA
Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
FDA Recall
Terminated
·LivaNova USA·Product code DWC·April 20, 2018
Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.
FDA Recall
Terminated
·Philips North America, LLC·Product code MWI·April 13, 2020
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.
FDA Recall
Terminated
·Philips North America, LLC·Product code MWI·April 13, 2020
Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
FDA Recall
Terminated
·Cook Urological, Inc.·Product code EZB·June 12, 2007