Recall Z-2902-2011
Spacelabs Healthcare, Llc · initiated June 8, 2011
Product
Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified.
Codes / lots: Model 91518, V1.00.14. Serial Numbers: 1518-000003, 1518-000008, 1518-000013, 1518-000014, 1518-000016, 1518-000024, 1518-000029, 1518-000036, 1518-000040, 1518-000044, 1518-000226, 1518-000228, 1518-000231, 1518-000233, 1518-000243, 1518-000349, 1518-000354, 1518-000355, 1518-000389, 1518-000399, 1518-000457, 1518-000752, 1518-000819, 1518-000825, 1518-000846, 1518-000948, 1518-000991, 1518-001341, 1518-001393, 1518-001394, 1518-001395, 1518-001522, 1518-001536, 1518-001654, 1518-001655, 1518-001708, 1518-001734, 1518-001736, 1518-001853, 1518-001972, 1518-002065, 1518-002089, 1518-002097, 1518-002114, 1518-002116, 1518-002117, 1518-002118, 1518-002119, 1518-002120, 1518-002121, 1518-002122, 1518-002123, 1518-002124, 1518-002125, 1518-002126, 1518-002127, 1518-002128, 1518-002129, 1518-002130, 1518-002131, 1518-002132, 1518-002133, 1518-002134, 1518-002135, 1518-002136, 1518-002137, 1518-002138, 1518-002139, 1518-002140, 1518-002141, 1518-002142, 1518-002143, 1518-002144, 1518-002145, 1518-002146, 1518-002147, 1518-002148, 1518-002149, 1518-002150, 1518-002151, 1518-002152, 1518-002153, 1518-002154, 1518-002155, 1518-002156, 1518-002157, 1518-002161, 1518-002162, 1518-002163…
Reason for recall
Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.
FDA-determined cause: Software design
Action taken
Spacelabs Healthcare, Llc. sent a "Customer Bulletin" dated June 20, 2011 to all affected customers. The customers were notified of the trend problem and are advised to follow the instructions in the Perioperative section and the ADMIT/DISCHARGE section of the users manual. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support or 1-425-657-7200 x5089.
Details
- Recall number
- Z-2902-2011
- Initiated
- June 8, 2011
- Posted by FDA
- August 1, 2011
- Terminated
- September 21, 2011
- Product code
- CBR – Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Quantity
- 481 units worldwide (333 units internationally and 148 units in the US)
- Distribution
- Worldwide Distribution: (USA) Nationwide distribution, and the countries of ARGENTINA, BAHRAIN, BOLIVIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, ECUADOR, EGYPT, FRANCE, INDIA, MEXICO, NICARAGUA, PARAGUAY, PERU, POLAND, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, CHINA, THAILAND, UNITED ARAB EMIRATES, U.K., URUGUAY, VENEZUELA, and VIETNAM.
- Recalling firm
- Spacelabs Healthcare, Llc, Issaquah, WA