Siemens Sensis Vibe Hemo system in combination with the recall
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic…
Why was Siemens Sensis Vibe Hemo system in combination with the recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 110 units US
- Distribution
- US Nationwide distribution.
- Recall date
- September 9, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)