FDAClass IIMarch 10, 2021

Sensis / Sensis Vibe systems with software version VD12 recall

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic…

Why was Sensis / Sensis Vibe systems with software version VD12 recalled?

System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

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?

Software version VD12 and equipped with HP Flex Pro-C PC Serial Numbers: 10704 18900 18901 103008 103014 103019 103022 103039 103040 103042 103047 103048 103053 103079 103080 103082 103086 103088 103089 103090 103115 103116 103117 103119 103123 103124 103130 103131 103137 103144 103145 103148 103152 103160 103170 103171 123004

Product
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
37 US
Distribution
US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.
Recall date
March 10, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls