Z-0841-2018 Class II Terminated
FDA device recall Z-0841-2018 was initiated by Philips Medical Systems (Cleveland) Inc on Jan 11, 2018 and is designated Class II. Reason for recall: 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect… The recall status is terminated (terminated May 20, 2019). Affected quantity: 63.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 14, 2018
- Initiation Date
- Jan 11, 2018
- Termination Date
- May 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63
Product Description
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Reason for Recall
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
Distribution Pattern
Domestic and Foreign
Code Information
Serial Numbers: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860025 860026 860027 860028 860029 860030 860031 860032 860033 860034 860035 860036 860037 860038 860039 860040 860041 860042 860043 860046 860048 860049 860050 860051 860052 860053 860054 860055 860056 860057 860058 860059 860060 860061 860062 860063 860064 860065 860066 860067 860068 860070 860071 860072 890002 860047
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0841-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026