CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
Reported: October 10, 2018 Initiated: July 31, 2018 #Z-0041-2019
Product Description
CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
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.
Details
- Recalling Firm
- Oridion Medical 1987 Ltd.
- Units Affected
- 113
- 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.
- Location
- Jerusalem
Frequently Asked Questions
What product was recalled? ▼
CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01. Recalled by Oridion Medical 1987 Ltd.. Units affected: 113.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-0041-2019.
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