2 results
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9ms
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Sources: EU EUDAMED, US FDA
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·June 27, 2012
C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (1) DRAPE SHEET 41" X 69" MEDIUM LIF (2) SURGICAL BLADE #10 CARBON STEEL (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CONTAINER 64oz WITH LID (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) MAYO STAND COVER REINFORCED UF (1) BAG SUTURE FLORAL (15) LAP SPONGES PRE-WASH XRD LIF (1) EAR ULCER SYRINGE 2oz UF (1) CORD UMBILICAL CLAMP L/F (1) WASH BASIN ?QT. (1) CAUTERY TIP POLISHER LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) FEEDING TUBE 8FR. 15" LONG (4) DRAPE UTILITY WITH TAPE UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014