FDA Medical Device Recalls (openFDA)
Oridion Medical 1987 Ltd.: Capnostream20 (INTL) M W/PRINTER, CS08660
- Recall number
- Z-0047-2019
- Recalling firm
- Oridion Medical 1987 Ltd.
- Product
- Capnostream20 (INTL) M W/PRINTER, CS08660
- Status
- Terminated
- Initiated
- 2018-07-31
- Posted
- not on file
- Terminated
- 2022-09-20
- 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.
- 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
- 23
- 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.
- Lot, serial or model codes
- B300001031 B300001047 B300001049 B300001052 B300001065 B300001453 B300001454 B300001468 B300001130 B300001325 B500001762 B500001843 B500001892 B500001915 B500001945 B500002146 B500002103 B500002150 B500002132 B502123108 B523123180 B523123182 B523123186
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 3001227743
- Firm city
- Jerusalem
- Firm state
- Har Hotzvim Industrial Park
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28