Recall Z-0060-2015— GE Healthcare, LLC

Name: FDA recall Z-0060-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-19

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-09-19, terminated 2016-09-13. It names one FDA 510(k) clearance: K071073. Product: GE Healthcare Carescape Patient Data Module. Reason: GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-09-19
Terminated: 2016-09-13
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K071073 — SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGe Medical Systems Information Technologies·cleared 2007-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Carescape Patient Data Module

Reason for recall

GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an

Data sourced from openFDA. This site is unofficial and independent of the FDA.