# FDA recall Z-1433-2018

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

## Product

Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4)   Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174,   11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

## 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-1433-2018
- **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-1433-2018

## Citation

> AI Analytics. FDA recall Z-1433-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1433-2018. Source: US FDA. Licensed CC0.

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