Z-1502-2020 Class II Terminated
FDA device recall Z-1502-2020 was initiated by Agfa N.V. on Feb 10, 2020 and is designated Class II. Reason for recall: Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. The recall status is terminated (terminated Mar 30, 2023). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 25, 2020
- Initiation Date
- Feb 10, 2020
- Termination Date
- Mar 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
Reason for Recall
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Distribution Pattern
US Nationwide distribution in the states of FL, VA.
Code Information
Serial Numbers: 00949, 1161