Maquet Medical Systems USA
Summary
- Total Recalls
- 40 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Known Names
maquet medical systems usa, maquet medical systems, usa
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1831-2024 | Class II | CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. | April 15, 2024 |
| Z-1077-2024 | Class II | BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOH | January 16, 2024 |
| Z-1076-2024 | Class II | Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with t | January 16, 2024 |
| Z-0978-2024 | Class II | BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with a | January 8, 2024 |
| Z-0977-2024 | Class II | BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with a | January 8, 2024 |
| Z-1053-2024 | Class II | Bubble Sensor (REF: 70105.5720) | December 28, 2023 |
| Z-0595-2024 | Class III | CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to | November 14, 2023 |
| Z-0605-2024 | Class II | Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part | November 13, 2023 |
| Z-0555-2024 | Class II | CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used t | November 6, 2023 |
| Z-0290-2024 | Class II | Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohel | October 12, 2023 |
| Z-0420-2024 | Class I | CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood o | October 10, 2023 |
| Z-1640-2023 | Class II | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item | May 18, 2023 |
| Z-1659-2023 | Class II | QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model | May 18, 2023 |
| Z-1658-2023 | Class II | QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model | May 18, 2023 |
| Z-1643-2023 | Class II | QUADROX-iR, used during cardiopulmonary bypass Model Item No. | May 18, 2023 |
| Z-1639-2023 | Class II | BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 70106782 | May 18, 2023 |
| Z-1657-2023 | Class II | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model | May 18, 2023 |
| Z-1641-2023 | Class II | QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Ite | May 18, 2023 |
| Z-1635-2023 | Class II | BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859 | May 18, 2023 |
| Z-1662-2023 | Class II | QUADROX-iR, used during cardiopulmonary bypass Model Item No. | May 18, 2023 |