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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips Medical Systems Nederlands: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Agency Publication Date: February 22, 2019
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Affected Products

Product: Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System

All systems

Product: Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System

All systems

Product: Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System

All systems

Product: Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System

All systems

Product: Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System

All systems

Product: Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System

All systems

Product: Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System

All systems

Product: SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System

All systems

Product: SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System

All systems

Product: Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System

All systems

Product: Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System

All systems

Product: Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System

All systems

Product: MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System

All systems

Product: MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System

All systems

Product: MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System

All systems

Product: Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System

All systems

Product: NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging System

All systems

Product: MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System

All systems

Product: Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System

All systems

Product: Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System

All systems

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82038
Status: Resolved
Manufacturer: Philips Medical Systems Nederlands
Manufactured In: Netherlands
Units Affected: 64 products (11226 total)
Agency Last Updated: October 1, 2020

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.