TY - JOUR AB - Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals PRODUCT HAZARD & CLINICAL SAFETY November 1, 2002 Volume 32 Ventilators Subject of Class I Recall Number 19 The FDA announced an “ongoing Class I recall” by Pulmonetic Systems Inc. IN THIS ISSUE (Colton, Calif.) of LTV Series Ventilators, Models: Recalls & Field a) LTV 1000 (cat. no. 10130), Recall no. Z-1047-2; Corrections b) Model LTV 950 (cat. no. 10950), Recall no. Z-1048-2; Monitor Slide Monitor May Fall .................... 156 c) Model LTV 900 (cat. no. 10638), Recall no. Z-1049-2; Recall of Airway d) Model LTV 800 (cat. no. 11800), Recall no. Z-1050-2. Products ................... 156 “FDA considers there to be a life threatening risk from continued use of Camera System ........ 158 these ventilators until damaged connectors are replaced,” said the FDA. Scales Recalled; Bolts According to the agency, the recall was begun because the device “shorts to May Break ................ 158 inoperative condition.” Pin Migration on Elbow Fixator .......... 158 The device is used to provide continuous or intermittent breathing sup- Nasal Packing .......... 158 port for patients who require mechanical ventilation. It is used for adults Compressor on and pediatric patients weighing at TI - Two New Glucose Test Meters JF - Biomedical Safety & Standards DA - 2002-11-01 UR - https://www.deepdyve.com/lp/wolters-kluwer-health/two-new-glucose-test-meters-3UAbYazTb4 SP - 160 EP - 160 VL - 32 IS - 19 DP - DeepDyve ER -