PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 91806
Description: SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 91806 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1416-2023 |
| Event ID | 91806 |
| Event Description | SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution. |
| Quantity | 1380 unts |
| Recall Reason | There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. |
| Device Classification | 20230426 |
| Device Code Info | 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 |
| Center Classification Date | 20230420 |
| Recall Initiation Date | 20230220 |
| Recalling Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
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