Maquet
FDA Regulatory Profile
Maquet appears in FDA public data with 7 recalls, 7 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3224-2026, Class II) was initiated on Aug 7, 2026. Its most recent 510(k) clearance was granted on May 18, 2022.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 7
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3224-2026 | Class II | PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. | Aug 7, 2026 |
| Z-2420-2025 | Class II | Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 7 | Jul 14, 2025 |
| Z-2502-2018 | Class II | VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL | Jun 14, 2018 |
| Z-1937-2018 | Class II | VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with | Apr 19, 2018 |
| Z-0490-2018 | Class II | Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extrac | May 22, 2017 |
| Z-0627-2013 | Class II | Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 7643 | Nov 2, 2012 |
| Z-2210-2012 | Class II | Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 | May 29, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K214120 | GSS610N21 Series Steam Sterilizer | May 18, 2022 |
| K201927 | Getinge GSS610N Series Steam Sterilizer | Mar 1, 2021 |
| K172159 | Getinge GSS67N Series Steam Sterilizer | Jan 30, 2018 |
| K130513 | VOLISTA 400; VOLISTA 600 | May 8, 2013 |
| K113679 | LUCEA LED SURGICAL LIGHT SYSTEM | Jan 12, 2012 |
| K070442 | POWERLED SURGICAL LIGHT SYSTEM | Mar 16, 2007 |
| K030071 | SERVO GUARD, MODEL 64 81 290 EH88E | Apr 26, 2004 |