Recall Z-0029-2019— Oridion Medical 1987 Ltd.

Name: FDA recall Z-0029-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-31

Class II · Terminated

Class II FDA medical device recall by Oridion Medical 1987 Ltd., initiated 2018-07-31, terminated 2022-09-20. It names one FDA 510(k) clearance: K082268. Product: Capnostream20 (US) M W/PRINTER, Part Number CS08659. Reason: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off..

Recalling firm: Oridion Medical 1987 Ltd.
Classification: Class II
Status: Terminated
Initiated: 2018-07-31
Terminated: 2022-09-20
Firm location: Jerusalem, Israel

510(k) clearances named in this recall

1 on FDA's record

K082268 — CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEXOridion Capnography, Inc.·cleared 2009-02-06

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

Capnostream20 (US) M W/PRINTER, Part Number CS08659

Reason for recall

The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

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