Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool suppo

FDA device recall Z-2921-2020 · posted 2020-08-28 · Terminated

Recall details

Recalling firm

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

Action taken

Siemens issued Customer Safety Advisory Notice distributed dated July 24 2020 to customers via AX048/20/S. Letter states reason for recall, health risk and action to take: If the connector linking the EtCO2 module to the HemoBox should become damaged or break, the operator shall not attempt to fix the connector or re-connect the cable to the HemoBox. Only Siemens Customer Service representative or a service provider authorized by Siemens Healthineers may resolve the issue. Siemens strongly recommends that you do not attempt to fix the connector or re-connect the cable to the HemoBox until the problem has been corrected by a service engineer. Siemens is currently developing a solution to eliminate the root cause of this problem. Our service organization will contact you when a solution has been initiated to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented.

Root cause

Process design

Status

Terminated

Product code

DQK

Quantity affected

110 units US

Distribution

US Nationwide distribution.

Date initiated

2020-07-24

Date posted

2020-08-28

Date terminated

2021-11-02

Location

Malvern, PA

Related 510(k) clearances