Tomtec Imaging Systems Gmbh Recall: TOMTEC-ARENA TTA2;software version no. 2.20 and lower;
Tomtec Imaging Systems Gmbh Recall: TOMTEC-ARENA TTA2;software version no. 2.20 and lower; is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Tomtec Imaging Systems Gmbh; Product: TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software
| Recalling firm | Tomtec Imaging Systems Gmbh |
|---|---|
| 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 TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)042 |
| Reason for recall | The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US:AL, AZ, CA, CT, IL, MA, MI,NC, NJ, NY, OH, PA, RI, TX, VA. OUS: Australia, Canada, Czech Republic, France, Germany, Italy, Latvia, Sweden, Switzerland, United Kingdom. |
| Recall initiated | 20190923 |
| Recall number | Z-2496-2020 |
| Category | device |
| Country | Germany |
$29/mo
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