WARNING LETTER Criticare Technologies, Inc was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 686915 Criticare Technologies, Inc. 6901 TPC Drive, Suite 300Orlando, FL 32822United States July 12, 2024 Inspection Dates: March 21, 2024, through May 10, 2024 Inspection Issue(s): These violations include, but are not limited...Read More

Company: Philips Respironics, Inc. Date of Enforcement Report: 5/23/2024 Class I PRODUCT OmniLab Advanced+ (OLA+) Ventilator Recall Number: Z-1817-2024 REASON: Philips Respironics, Inc. is updating use instructions for OmniLab Advanced+ (OLA+) Ventilator due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss. Philips will correct the affected OLA+ to...Read More