Draeger, Inc.: Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use

Hazard

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Details from the source

Reason for recall: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. Distribution: Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Belgium, Brazil, Chili, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, H Quantity: 223 Lot/code info: Lot Code: UDI-DI Number: 04048675556183 Serial Numbers Distributed in the US: ASTA-0307,ASTA-0309,ASTA-0311,ASTA-0349,ASTA-0350,ASTA-0409 ASTB-0048 ASTC-0244,ASTC-0245 ASTD-0008,ASTD-0009,ASTD-0010,ASTD-0011,ASTD-0013,ASTD-0014,ASTD-0212,ASTD-0239 ASTH-0307,ASTH-0308,ASTH-0309,ASTH-0310,ASTH-0311,ASTH-0332,ASTH-0333,ASTH-0334, ASTH-0335,ASTH-0336,ASTH-0383,ASTH-0384 ASTJ-0014 ASUA-0469,ASUA-0483,ASUA-0484,ASUA-0486,ASUA-0488 ASUB-0093,ASUB-0169,ASUB-0170,ASUB-0171,ASUB-0172,ASUB-0173,ASUB-0174,ASUB-0175, ASUB-0176,ASUB-0183,ASUB-0184,ASUB-0185,ASUB-0186,ASUB-0187,ASUB-0215,ASUB-0216, ASUB-0217,ASUB-0218,ASUB-0219,ASUB-0221,ASUB-0222,ASUB-0250,ASUB-0251,ASUB-0266, ASUB-0267, ASUB-0268,ASUB-0269,ASUB-0270 ASUC-0067,ASUC-0068,ASUC-0069,ASUC-0072,ASUC-0114,ASUC-0115,ASUC-0146,ASUC-0148, ASUC-0149,ASUC-0150,ASUC-0151,ASUC-0153,ASUC-0155,ASUC-0156,ASUC-0157,ASUC-0158, ASUC-0174,ASUC-0175,ASUC-0176,ASUC-0178,ASUC-0179,ASUC-0180,ASUC-0181,ASUC-0182, ASUC-0183,ASUC-0184,ASUC-0185,ASUC-0186,ASUC-0187,ASUC-0188,,ASUC-0189,ASUC-0190, ASUC-0191,ASUC-0192,ASUC-0193,ASUC-0194,ASUC-0196,ASUC-0197,ASUC-0198,ASUC-0199, ASUC-0200,ASUC-0201,ASUC-0202,ASUC-0211,ASUC-0212,ASUC-0213,ASUC-0214,ASUC-0215, ASUC-0216,ASUC-0217,ASUC-0238,ASUC-0239,ASUC-0285,ASUC-0368,ASUC-0369,ASUC-0370, ASUC-0371,ASUC-0372,ASUC-0373 ASUD-0142,ASUD-0142,ASUD-0143,ASUD-0143,ASUD-0144,ASUD-0145,ASUD-0146,ASUD-0147, ASUD-0164,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0187,ASUD-0188,ASUD-0189, ASUD-0190,ASUD-0191,ASUD-01

UPC codes

04048675556183

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.