Philips North America Llc
Philips North America Llc has 563 FDA recalls (9 Class I), 20 inspections, 2 510(k) clearances and 4 compliance actions on record.
- Latest recall
- Z-3313-2026 · Class II · Aug 28, 2026
- Latest inspection
- Dec 13, 2023 · NAI
- Latest 510(k)
- Apr 5, 2022
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 563 (9 Class I) | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 2 | Oct 4, 2026 | Not stated | Current |
| Inspections | 20 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 4 | Oct 23, 2026 | Not stated | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Philips Medical Systems | 82 | 221 | 1 | 0 | Aug 21, 2026 (Z-0078-2027) |
| Respironics | 1 | 173 | 10 | 1 | Apr 27, 2012 (Z-2024-2012) |
| Spectranetics | 1 | 42 | 0 | 0 | Jan 15, 2016 (Z-0758-2016) |
| Volcano Corporation | 22 | 55 | 0 | 0 | Jan 19, 2022 (Z-0885-2022) |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-3313-2026 | Class II | MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11… | Aug 28, 2026 |
| Z-3310-2026 | Class II | Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3… | Aug 28, 2026 |
| Z-3316-2026 | Class II | Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13; | Aug 28, 2026 |
| Z-3317-2026 | Class II | Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13; | Aug 28, 2026 |
| Z-3315-2026 | Class II | SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and… | Aug 28, 2026 |
| Z-3308-2026 | Class II | Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3… | Aug 28, 2026 |
| Z-3314-2026 | Class II | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T… | Aug 28, 2026 |
| Z-3309-2026 | Class II | Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T)… | Aug 28, 2026 |
| Z-3318-2026 | Class II | Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148… | Aug 28, 2026 |
| Z-3311-2026 | Class II | Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3… | Aug 28, 2026 |
| Z-3307-2026 | Class II | Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE)… | Aug 28, 2026 |
| Z-3312-2026 | Class II | MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11… | Aug 28, 2026 |
| Z-3235-2026 | Class II | Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148… | Aug 21, 2026 |
| Z-3238-2026 | Class II | Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3… | Aug 21, 2026 |
| Z-3239-2026 | Class II | Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3… | Aug 21, 2026 |
| Z-3234-2026 | Class II | Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; | Aug 21, 2026 |
| Z-3233-2026 | Class II | Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; | Aug 21, 2026 |
| Z-3240-2026 | Class II | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT… | Aug 21, 2026 |
| Z-3242-2026 | Class II | MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade); | Aug 21, 2026 |
| Z-3237-2026 | Class II | Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3… | Aug 21, 2026 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 13, 2023 | Cambridge, MA | Devices | No Action Indicated (NAI) | 3006648320 |
| Oct 27, 2022 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 1000524572 |
| Aug 20, 2021 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 1000524572 |
| Mar 25, 2020 | Bothell, WA | Devices | No Action Indicated (NAI) | 1000524572 |
| Dec 4, 2018 | Andover, MA | Devices | Official Action Indicated (OAI) | 1218950 |
| Dec 3, 2018 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 1000524572 |
| Mar 3, 2017 | Cambridge, MA | Devices | Voluntary Action Indicated (VAI) | 3006648320 |
| Jun 18, 2015 | Andover, MA | Devices | Official Action Indicated (OAI) | 1218950 |
| Apr 21, 2015 | Bothell, WA | Devices | Official Action Indicated (OAI) | 1000524572 |
| Dec 12, 2013 | Andover, MA | Devices | No Action Indicated (NAI) | 1218950 |
| Apr 24, 2013 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 1000524572 |
| Aug 29, 2012 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 1000524572 |
| Apr 13, 2012 | Cambridge, MA | Devices | Voluntary Action Indicated (VAI) | 3006648320 |
| Mar 19, 2012 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 1000524572 |
| Sep 28, 2011 | Andover, MA | Devices | No Action Indicated (NAI) | 1218950 |
| Dec 14, 2010 | Andover, MA | Devices | Voluntary Action Indicated (VAI) | 1218950 |
| Aug 9, 2010 | Bothell, WA | Devices | Official Action Indicated (OAI) | 1000524572 |
| Jul 18, 2009 | Cambridge, MA | Devices | Voluntary Action Indicated (VAI) | 3006648320 |
| Mar 10, 2009 | Andover, MA | Devices | Official Action Indicated (OAI) | 1218950 |
| Dec 16, 2008 | Bothell, WA | Devices | No Action Indicated (NAI) | 1000524572 |