# FDA recall Z-1441-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2018-03-16.

## Product

Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498       Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

## Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

## Distribution

Worldwide Distribution - US Nationwide; International - Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia,   Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Chile,  China, Colombia, Congo (Democratic Republic of the), Costa Rica,   C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic,  Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary,  Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan,  Kazakhstan, Kenya, Republic of Korea - South Korea, Kuwait, Kyrgyzstan,   Latvia, Lebanon, Lesotho, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mauritius, Mexico, Monaco, Mongolia,  Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia,   New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of  Panama

## Key facts

- **Recall number:** Z-1441-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-16
- **Report date:** 2018-04-25
- **Termination date:** 2020-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1441-2018

## Citation

> AI Analytics. FDA recall Z-1441-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1441-2018. Source: US FDA. Licensed CC0.

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