Device product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Z-2301-2016
Product summary
- Event
- Event 74648
- Status
- Terminated
- Classification
- Class II
- Quantity
- 109 sites have the affected versions
- Official record key
device-enforcement:Z-2301-2016
Official wording
Reason: Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Code information: Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.
Distribution pattern: Worldwide Distribution -- USA, New Zealand, and United Kingdom.
Derived failure modes
-
Unknown
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.