FDA Device

Draeger Medical Apollo Anesthesia Machine, catalog number 8606500

Hazard

Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed.

What You Should Do

Remedy

Draeger Medical sent a Medical Device Recall letter to their customers via certified mail on 8/22/08 informing them of the problem. Until the exchange of affected printed circuit boards has been implemented, the firm is recommending that users closely monitor all device displays and error messages and if applicable act in accordance with the advisory statements and remedial information provided in the Instructions for Use as well as making provisions for alternative patient care measures.

Products

Draeger Medical Apollo Anesthesia Machine, catalog number 8606500
Brand
Draeger Medical, Inc.
UPC
Catalog number 8606500. Serial numbers ARZC-0142, ARZC-0143, ARZC-0144, ARZC-0145, ARZC-0146, ARZC-0147, ARZC-0148, ARZC-0149, ARZC-0150, ARZC-0151, ARZC-0152, ARZC-0153, ARZC-0172, ARZC-0173, ARZC-0174, ARZC-0175, ARZC-0176, ARZC-0177, ARZC-0192, ARZC-0193,ARZC-0196, ARZC-0197, ARZC-0198, ARZC-0199, ARZC-0200, ARZD-0001, ARZD-0002, ARZD-0003, ARZD-0010, ARZD-0011, ARZD-0012, ARZD-0013, ARZD-0014, ARZD-0015, ARZD-0016, ARZD-0017, ARZD-0018, ARZD-0019, ARZD-0020, ARZD-0021, ARZD-0022, ARZD-0023, ARZD-0024, ARZD-0025, ARZD-0026, ARZD-0027, ARZD-0028, ARZD-0029, ARZD-0030, ARZD-0031, ARZD-0032, ARZD-0033, ARZD-0034, ARZD-0035, ARZD-0036, ARZD-0037, ARZD-0038, ARZD-0039, ARZD-0040, ARZD-0041, ARZD-0042, ARZD-0043, ARZD-0044, ARZD-0058, ARZD-0059, ARZD-0060, ARZD-0061, ARZD-0062, ARZD-0063, ARZD-0064, ARZD-0065, ARZD-0066, ARZD-0067, ARZD-0068, ARZD-0069, ARZD-0070, ARZD-0071, ARZD-0072, ARZD-0073, ARZD-0074, ARZD-0075, ARZD-0076, ARZD-0077, ARZD-0078, ARZD-0079, ARZD-0080, ARZD-0081, ARZD-0082, ARZD-0083, ARZD-0084, ARZD-0085, ARZD-0086, ARZD-0087, ARZD-0117, ARZD-0118, ARZD-0119, ARZD-0120, ARZD-0121, ARZD-0122, ARZD-0125, ARZD-0126, ARZD-0127, ARZD-0128, ARZD-0129, ARZD-0130, ARZD-0131, ARZD-0132, ARZD-0133, ARZD-0134, ARZD-0135, ARZD-0136, ARZD-0183, ARZD-0184, ARZD-0185, ARZD-0186, ARZD-0187, ARZD-0188, ARZD-0189, ARZD-0190, ARZD-0191, ARZD-0192, ARZD-0193, ARZD-0194, ARZD-0195, ARZD-0196, ARZD-0197, ARZD-0198, ARZD-0199, ARZD-0200, ARZD-0201, ARZD-0202, ARZD-0203, ARZD-0255, ARZD-0256, ARZD-0257, ARZD-0258, ARZD-0259, ARZD-0260, ARZD-0261, ARZD-0262, ARZD-0263, ARZD-0264, ARZD-0265, ARZD-0266, ARZD-0267, ARZD-0268, ARZD-0269, ARZD-0270, ARZD-0271, ARZE-0001, ARZE-0002, ARZE-0003, ARZE-0004, ARZE-0005, ARZE-0008, ARZE-0009, ARZE-0010, ARZE-0023, ARZE-0024, ARZE-0025, ARZE-0026, ARZE-0027, ARZE-0028, ARZE-0029, ARZE-0030, ARZE-0059, ARZE-0060, ARZE-0061, ARZE-0062, ARZE-0063, ARZE-0064, ARZE-0065, ARZE-0115, ARZE-0116, ARZE-0173, ARZE-0174, ARZE-0175, ARZE-0176, ARZE-0189, ARZE-0190, ARZE-0191, ARZE-0192, ARZE-0193, ARZE-0194, ARZE-0195, ARZE-0196, ARZE-0197, ARZE-0198, ARZE-0199, ARZE-0200, ARZE-0201, ARZE-0202, ARZE-0203, ARZE-0204, ARZE-0214, ARZE-0215, ARZE-0216, ARZF-0011, ARZF-0012, ARZF-0013, ARZF-0014, ARZF-0015, ARZF-0016, ARZF-0017, ARZF-0018, ARZF-0019, ARZF-0020, ARZF-0021, ARZF-0022, ARZF-0023, ARZF-0024, ARZF-0025, ARZF-0026, ARZF-0027, ARZF-0028, ARZF-0029, ARZF-0030, ARZF-0031, ARZF-0084, ARZF-0087, ARZF-0088, ARZF-0089, ARZF-0090, ARZF-0091, ARZF-0092, ARZF-0093, ARZF-0094, ARZF-0095, ARZF-0096, ARZF-0097, ARZF-0098, ARZF-0099, ARZF-0100, ARZF-0101, ARZF-0102, ARZF-0103, ARZF-0104, ARZF-0105, ARZF-0106, ARZF-0107, ARZF-0108, ARZF-0109, ARZF-0110, and ARZF-0111.

Units Affected

214 units