Company: Philips Medical Systems Nederlands Date of Enforcement Report: 1/8/2019 Class II PRODUCT Ingenia Elition S, Ingenia Elition X Recall Number: Z-0694-2019 REASON During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement. RECALLING FIRM/MANUFACTURER Philips Medical Systems Nederlands, Best, Netherlands on 12/3/2018. Voluntary:...Read More
Company: Agfa-Gevaert, N.V. Date of Enforcement Report: 1/7/2019 Class II PRODUCT DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton...Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 12/29/2018 Class II PRODUCT GE Magnetic Resonance System Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use Recall Number: Z-0693-2019 REASON Possible incorrect software version loaded. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on 11/15/2018. Voluntary: Firm Initiated...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.