Z-0547-2019 Class II Terminated
FDA device recall Z-0547-2019 was initiated by Philips Medical Systems (Cleveland) Inc on Oct 18, 2018 and is designated Class II. Reason for recall: There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall The recall status is terminated (terminated Aug 3, 2021).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2018
- Initiation Date
- Oct 18, 2018
- Termination Date
- Aug 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Reason for Recall
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Distribution Pattern
US Nationwide Distribution
Code Information
System Serial Number: 2598 3008 3098 4001 4002 4003 4005 4006 4007 4008 4009 4010 4011 4012 4014 4015 4016 4020 4021 4022 4023 4026 4027 4028 4029 4030 4031 4032 4033 4034 4035 4039 4040 4044 4045 4047 4048 4049 4050 4052 4053 4054 4056 4058 4059 4061 4062 4063 4064 4065 4066 4067 30099 40004 40005 40006 40007 40008 40009 40010 40011 40012 40014 40015 40016 40018 40019 40020 40021 40023 40025 40028 40029 40031 40032 40034 62986554 4008/6086 4039/7128 728251_859-1766
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0547-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026