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[Recalled] Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Mode

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductComputed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 113
Brand / manufacturerSiemens Medical Solutions USA, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2500-2021
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date18 August 2021
EAN / barcode11061610

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Siemens Medical Solutions USA, Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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