FDA Device recall Z-0226-2022
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Comb…
- FDA Device
- Class II
- ongoing
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Comb… by Siemens Medical Solutions Usa, citing system operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0226-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-05 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
Reason
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
Identifiers
| code_info | Serial Numbers: 15916 15908 103108 103111 15917 103047 103048 103171 103181 103182 103185 103191 103193 103301 103170 1…Serial Numbers: 15916 15908 103108 103111 15917 103047 103048 103171 103181 103182 103185 103191 103193 103301 103170 103223 103225 103247 15939 103313 103315 100413 100414 100417 100402 14612 14613 101016 101017 101019 101020 101022 101029 101031 101032 101036 18903 15945 15946 103359 15931 100263 103424 15953 103274 15941 15942 103319 103320 103321 103323 103325 103328 103330 103333 103334 103335 103344 100216 103337 15514 15515 100154 100156 100157 14803 14804 18502 15544 15545 100416 102008 103413 15561 101082 101083 101084 18902 14603 100208 100209 102138 103437 15560 101090 102019 102021 102025 102029 15559 101088 15819 15820 102145 102147 103160 15539 100346 100349 103314 102199 15830 102323 102324 102325 15832 15833 103079 122042 123004 15005 15147 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 122006 122026 102214 102216 102219 102222 102272 101096 102181 102242 102068 102069 102078 102080 102093 102097 15828 15829 102221 103123 103124 1031 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0226-2022%22
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