Z-2176-2018 Class II Terminated
FDA device recall Z-2176-2018 was initiated by Philips Medical Systems (Cleveland) Inc on Mar 30, 2018 and is designated Class II. Reason for recall: The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical… The recall status is terminated (terminated Apr 14, 2020). Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 20, 2018
- Initiation Date
- Mar 30, 2018
- Termination Date
- Apr 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
Reason for Recall
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Distribution Pattern
Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
Code Information
System Serial Numbers: 5380, 5379, 5520, 5524, 5538, 5539, 5549, 5779, 5792, 5778, 5808, 5887, 5888, 5973, 6020, 6026, 6110, 6097, 6352, 6424
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2176-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026