Z-1780-2015Class II
Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and...
Philips North America LLC / initiated 2015-03-06 / Terminated / root cause: manufacturing process
Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems on . FDA classified it as Class II and gives the reason as "The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1780-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips North America LLC
- Product
- Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Product code
- OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Reason for recall
- The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.
- Quantity in commerce
- 9 units
- Distribution
- Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
- Product codes and lots
- Model #: 882380; Serial #s: 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013 & 11014.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1759-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1760-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1761-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1762-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1763-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1764-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1765-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1766-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1767-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1768-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1769-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1770-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1771-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1772-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1773-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1774-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1775-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1776-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1777-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1778-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1779-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1780-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1781-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1782-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1783-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1784-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1785-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1786-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1787-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1788-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1789-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1790-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1791-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1792-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1793-2015 | Class II | Terminated | Voluntary: Firm initiated |
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