Recall Z-0962-2022— Siemens Medical Solutions USA, Inc
Class II · Ongoing
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-03-07. It names 5 FDA 510(k) clearances: K211373, K200524, K192061 and 2 more. Product: SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system. Reason: Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-07
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K211373 — SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software
- K200524 — SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
- K192061 — SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO
- K173632 — SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
- K163296 — SOMATOM go.Up, SOMATOM go.Now
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
Reason for recall
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
Data sourced from openFDA. This site is unofficial and independent of the FDA.