The Recall Desk

Manufacturer

Tomtec Imaging Systems Gmbh

1 recall in our database name Tomtec Imaging Systems Gmbh as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2020-07-15

Of the 1 recalls from Tomtec Imaging Systems Gmbh we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-2496-2020·2020-07-15

    Tomtec ARENA TTA2 Software Recalled for Potential Data Storage Error

    Tomtec Imaging Systems is recalling ARENA TTA2 software versions 2.20 and lower because measurements from one study might be stored to another.

    Product
    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement T
    Category
    Medical Device
    Distribution
    15 states