# FDA recall Z-1435-2018

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

## Product

Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8)  Achieva 1.5T Model 781382     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-1435-2018
- **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-1435-2018

## Citation

> AI Analytics. FDA recall Z-1435-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1435-2018. Source: US FDA. Licensed CC0.

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