Z-1437-2018Class II
Ingenia 1.5T CX, Models 781261 & 781262
Philips North America LLC / initiated 2018-03-16 / Terminated / root cause: manufacturing process
Philips Electronics North America Corporation began a recall of Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images... on . FDA classified it as Class II and gives the reason as "Potential risk for helium gas inside the MR examination room during a magnet quench". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1437-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips North America LLC
- Product
- Ingenia 1.5T CX, Models 781261 & 781262 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.
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- Reason for recall
- Potential risk for helium gas inside the MR examination room during a magnet quench
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use: Release of helium gas in the examination room" If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: " Immediately remove all persons from the examination room. " Do not switch off air circulation and ventilation in the examination room. " Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level. "Emergency procedures" The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. (Instructions for Use R5.3) Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
- Quantity in commerce
- 8,205 units in total
- 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, Papua New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen & Zimbabwe.
- Product codes and lots
- (Added 6/25/18): 41158 70743 70200
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1430-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1431-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1432-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1433-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1434-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1435-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1436-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1437-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1438-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1439-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1440-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1441-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1442-2018 | Class II | Terminated | Voluntary: Firm initiated |
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