Recall Z-2139-2021— GE Healthcare, LLC

Name: FDA recall Z-2139-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-21

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-05-21. It names one FDA 510(k) clearance: K071073. Product: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.. Reason: Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-05-21
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

CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

Reason for recall

Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.

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