Device recall: CAPNOSTREAM 20 (US) N, Part Number CS08651
FDA enforcement event 80895 is a device recall by Oridion Medical 1987 Ltd. of Jerusalem, initiated 31 Jul 2018 and classified Class II, with 37 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 20 Sep 2022. Initiation: voluntary: firm initiated. Oridion Medical 1987 Ltd. has 2 enforcement events on this register, with a median of 37 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Oridion Medical 1987 Ltd., Jerusalem, Israel.
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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0020-2019 | CAPNOSTREAM 20 (US) N, Part Number CS08651 | 3143 | Class II | Terminated | 10 Oct 2018 |
| Z-0021-2019 | CAPNOSTREAM 20P (US) N, Part Number CS08651-01 | 1819 | Class II | Terminated | 10 Oct 2018 |
| Z-0022-2019 | CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02 | 10356 | Class II | Terminated | 10 Oct 2018 |
| Z-0023-2019 | CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03 | 2976 | Class II | Terminated | 10 Oct 2018 |
| Z-0024-2019 | CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657 | 1798 | Class II | Terminated | 10 Oct 2018 |
| Z-0025-2019 | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02 | 2806 | Class II | Terminated | 10 Oct 2018 |
| Z-0026-2019 | CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01 | 1038 | Class II | Terminated | 10 Oct 2018 |
| Z-0027-2019 | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 | 696 | Class II | Terminated | 10 Oct 2018 |
| Z-0028-2019 | Capnostream20 (US) M, Part Number CS08653 | 769 | Class II | Terminated | 10 Oct 2018 |
| Z-0029-2019 | Capnostream20 (US) M W/PRINTER, Part Number CS08659 | 500 | Class II | Terminated | 10 Oct 2018 |
| Z-0030-2019 | Capnostream20 (US) M TO MASIMO, Part Number CS08750 | 1 | Class II | Terminated | 10 Oct 2018 |
| Z-0031-2019 | Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 | 400 | Class II | Terminated | 10 Oct 2018 |
| Z-0032-2019 | Capnostream20 (US) N REFURBISHED, Part Number CS78651 | 46 | Class II | Terminated | 10 Oct 2018 |
| Z-0033-2019 | Capnostream20 (US)M REFURBISHED, Part Number CS78653 | 43 | Class II | Terminated | 10 Oct 2018 |
| Z-0034-2019 | Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657 | 48 | Class II | Terminated | 10 Oct 2018 |
| Z-0035-2019 | Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659 | 22 | Class II | Terminated | 10 Oct 2018 |
| Z-0036-2019 | CAPNOSTREAM 20 (INTL) N, Part Number CS08652 | 245 | Class II | Terminated | 10 Oct 2018 |
| Z-0037-2019 | CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01 | 113 | Class II | Terminated | 10 Oct 2018 |
| Z-0038-2019 | CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02 | 474 | Class II | Terminated | 10 Oct 2018 |
| Z-0039-2019 | CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03 | 264 | Class II | Terminated | 10 Oct 2018 |
| Z-0040-2019 | CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658 | 144 | Class II | Terminated | 10 Oct 2018 |
| Z-0041-2019 | CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01 | 113 | Class II | Terminated | 10 Oct 2018 |
| Z-0042-2019 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02 | 383 | Class II | Terminated | 10 Oct 2018 |
| Z-0043-2019 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03 | 192 | Class II | Terminated | 10 Oct 2018 |
| Z-0044-2019 | Capnostream20 (INTL) M, CS08654 | 56 | Class II | Terminated | 10 Oct 2018 |
| Z-0045-2019 | Capnostream20 M ADULT ICU (CPM), CS08654RA | 5 | Class II | Terminated | 10 Oct 2018 |
| Z-0046-2019 | Capnostream20 M NICU (CPM), CS08654RN | 262 | Class II | Terminated | 10 Oct 2018 |
| Z-0047-2019 | Capnostream20 (INTL) M W/PRINTER, CS08660 | 23 | Class II | Terminated | 10 Oct 2018 |
| Z-0048-2019 | Capnostream20 M W/PRINTER CYVITAL, CS08796 | 3 | Class II | Terminated | 10 Oct 2018 |
| Z-0049-2019 | Capnostream20 N W/PRINTER CYVITAL, CS08798 | 5 | Class II | Terminated | 10 Oct 2018 |
| Z-0050-2019 | Capnostream20 N CYVITAL, CS08799 | 20 | Class II | Terminated | 10 Oct 2018 |
| Z-0051-2019 | Capnostream20 (INTL) N REFURBISHED, CS78652 | 5 | Class II | Terminated | 10 Oct 2018 |
| Z-0052-2019 | Capnostream20 (INTL) M REFURBISHED, CS78654 | 11 | Class II | Terminated | 10 Oct 2018 |
| Z-0053-2019 | Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658 | 6 | Class II | Terminated | 10 Oct 2018 |
| Z-0054-2019 | Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660 | 8 | Class II | Terminated | 10 Oct 2018 |
| Z-0055-2019 | CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV | 16 | Class II | Terminated | 10 Oct 2018 |
| Z-0056-2019 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03 | 56 | Class II | Terminated | 10 Oct 2018 |
Context
Other enforcement events for Oridion Medical 1987 Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 17 Feb 2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set | Device | Class II | 10 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Sep 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.