Z-0072-2021 Class II Terminated
FDA device recall Z-0072-2021 was initiated by CHANGE HEALTHCARE CANADA COMPANY on August 25, 2020 and is designated Class II. Reason for recall: Software defect which may potentially result in one or more images missing in a study The recall status is terminated (terminated February 16, 2021). Affected quantity: 5 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- August 25, 2020
- Termination Date
- February 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices
Product Description
Change Healthcare Radiology Solutions 14.0
Reason for Recall
Software defect which may potentially result in one or more images missing in a study
Distribution Pattern
Domestic distribution to VT, MS, WV, NE
Code Information
All Model number 14.0 UDI (01)17540262030020(10)140000