Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 100413 100414 100417 101016 101017 101019 101020 101022 101029 101031 101036 100263 100416 102008 101083 102138 102019 102021 102025 102029 102145 102147 100346 100349 102199 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 102272 102068 102069 102078 102080 102093 102221 100163 100165 100306 100309 101056 101099 101100 101101 101060 101068 101069 101070 101071 101072 100064 100422 100279 100408 100410 100411 100412 101043 102162 102285 102286 102183 100231 102060 102062 102049 102051 102057 102030 102031 101008 101093 101094 100175 100176 102226 101097 102269 102273 102276 102278 102279 102283 102193 102155 102157 102174 102182 102181 102214 102216 102219 102222 102237 102242 100391 101089 101095 102274 101018 102143 102091 9/01/20 Expanded S/N: 11007641 11007641 11007641 ***9/28/20 Expanded S/N*** 103053 103040 103042 103008
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
Product Codes/Lot Numbers:
Serial Numbers: 100413 100414 100417 101016 101017 101019 101020 101022 101029 101031 101036 100263 100416 102008 101083 102138 102019 102021 102025 102029 102145 102147 100346 100349 102199 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 102272 102068 102069 102078 102080 102093 102221 100163 100165 100306 100309 101056 101099 101100 101101 101060 101068 101069 101070 101071 101072 100064 100422 100279 100408 100410 100411 100412 101043 102162 102285 102286 102183 100231 102060 102062 102049 102051 102057 102030 102031 101008 101093 101094 100175 100176 102226 101097 102269 102273 102276 102278 102279 102283 102193 102155 102157 102174 102182 102181 102214 102216 102219 102222 102237 102242 100391 101089 101095 102274 101018 102143 102091 9/01/20 Expanded S/N: 11007641 11007641 11007641 ***9/28/20 Expanded S/N*** 103053 103040 103042 103008
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2921-2020
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.