Z-0056-2019 Class II Terminated
FDA device recall Z-0056-2019 was initiated by Oridion Medical 1987 Ltd. on July 31, 2018 and is designated Class II. 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. The recall status is terminated (terminated September 20, 2022). Affected quantity: 56.
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- July 31, 2018
- Termination Date
- September 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56
Product Description
Reason for Recall
Distribution Pattern
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.