Z-1416-2023 Class II Ongoing
FDA device recall Z-1416-2023 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on February 20, 2023 and is designated Class II. Reason for recall: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. The recall status is ongoing. Affected quantity: 1461 units (236 US, 1225 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- February 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1461 units (236 US, 1225 OUS)
Product Description
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Reason for Recall
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI: (01)00884838088566 SmartPerfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software license key: 459801530271 sw key SmartPerfusion