Draeger Medical Apollo Anesthesia Machine, catalog number 8606500
This recall has been terminated (originally issued October 8, 2008).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- August 22, 2008
- Posted
- October 8, 2008
- Terminated
- September 1, 2009
- Recall Number
- Z-0087-2009
- Quantity
- 214 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.