Z-0053-2019Class II

Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658

Name: Z-0053-2019 Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
Creator: Oridion Medical 1987 Ltd.
Published: 2018-07-31
License: https://open.fda.gov/license/

Oridion Medical 1987 Ltd. / initiated 2018-07-31 / Terminated / root cause: manufacturing process

FDA source

Oridion Medical 1987 Ltd. began a recall of Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658 on 2018-07-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0053-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-31
Posted: 2018-10-03
Terminated: 2022-09-20
Recalling firm: Oridion Medical 1987 Ltd.
Product: Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
Product code: DQA Oximeter
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Correction notification letters dated 7/31/18 were distributed to customers. The letters included the following instructions for customers: Share this notification with all care environments where the Capnostream" 20 and Capnostream" 20p bedside patient monitors are used, particularly in the areas where nurse call may be enabled (general care floors). If your facility has distributed these bedside patient monitors to other persons or facilities, please promptly forward a copy of this letter to those recipients. Medtronic is recommending continued use of Capnostream" devices. Users should confirm that the date/time is accurately displayed. If the date/time requires reset, all user defined settings, such as alarms and nurse call, will also require reset until the software is updated. Please follow the instruction in the Operators Manual to set user-defined default settings. The Operators Manual is available at http://www.medtronic.com/covidien/enus/support/product-manuals.html, refer to the Institutional Settings section. Return the completed Acknowledgement and Receipt Form by fax or email even if you have no inventory. In October 2018, download the software update from the Medtronic website via the following link which includes directions on how to download and install the software: http://www.medtronic.com/covidien/en-us/support/patient-monitoring-equipmentsoftware-upgrades.html.
Quantity in commerce: 6
Distribution: The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.
Product codes and lots: B200001046 B400001071 B200001463 B440112961 B200001098 B200001752

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0053-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0020-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0021-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0022-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0023-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0024-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0025-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0026-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0027-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0028-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0029-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0030-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0031-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0032-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0033-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0034-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0035-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0036-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0037-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0038-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0039-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0040-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0041-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0042-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0043-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0044-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0045-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0046-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0047-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0048-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0049-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0050-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0051-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0052-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0053-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0054-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0055-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0056-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03

Product code DQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)