FDAFDA · Food and drugs·Recall number Z-0034-2019
Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
Published October 10, 2018 · Recall initiated: July 31, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Oridion Medical 1987 Ltd.
- Distributor
- 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
- B200001412 B200001550 B200001579 B200001485 B200002038 B200001062 B200001148 B200001184 B200001273 B200001303 B200001320 B200001332 B200001351 B200001372 B200001384 B200001444 B200001083 B200001394 B200001552 B200001200 B200001233 B200001553 B200001121 B200001123 B200001446 B200001036 B200001124 B200001125 B200001130 B200001035 B200001112 B200001482 B200001095 B400002305 B200001143 B200001252 B400002682 B200001064 B200001435 B200001489 B400002288 B200001136 B200001355 B200001608 B200001998 B200001349 B200001066 B410123252
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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