DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

Recall Insight

This FDA Devices action (record #Z-1326-2022) was formally reported on July 20, 2022, with the manufacturer initiating the action on May 19, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips Medical Systems DMC GmbH is listed as the recalling firm, operating out of Hamburg. Federal records indicate 140 systems in total, (Updated 1/30/2023). units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the f… Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.