| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | August 11, 2021 |
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| Create Date | September 03, 2021 |
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| Recall Status1 |
Completed |
| Recall Number | Z-2412-2021 |
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| Recall Event ID |
88491 |
| 510(K)Number | K162931 |
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| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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| Product | Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities
Model: 781315 |
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| Code Information |
Model: 78135
Serial Number Unique Device Identifier (UDI#)
61019 (01)00884838099715
61028 (01)00884838099715
61001 (01)00884838099715
61004 (01)00884838099715
61023 (01)00884838099715
61008 (01)00884838099715
61026 (01)00884838099715
61034 (01)00884838099715
61046 (01)00884838099715
61025 (01)00884838099715
61035 (01)00884838099715
61042 (01)00884838099715
61040 (01)00884838099715
61041 (01)00884838099715(21)61041
61007 (01)00884838099715
61014 (01)00884838099715
61018 (01)00884838099715
61000 N/A
61003 (01)00884838099715
61002 N/A
61006 N/A
61009 N/A
61013 N/A
61017 (01)00884838099715(21)61017
61032 (01)00884838099715(21)61032
61015 N/A
61005 (01)00884838099715
61020 (01)00884838099715
61043 (01)00884838099715
61029 (01)00884838099715
61030 (01)00884838099715
61033 (01)00884838099715(21)61033
61052 (01)00884838099715(21)61052
61064 (01)00884838099715(21)61064
61027 (01)00884838099715
61016 (01)00884838099715
61022 (01)00884838099715
61044 (01)00884838099715
61050 (01)00884838099715
61047 (01)00884838099715(21)61047
61053 (01)00884838099715(21)61053
61049 (01)00884838099715(21)61049
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Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
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Manufacturer Reason
for Recall | When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment |
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FDA Determined
Cause 2 | Device Design |
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| Action | Philips notified U.S. customers an Urgent Medical Device Correction letter on 8/11/21. Letter states reason for recall, health risk and action to take:
Philips advises that customers continue to utilize the primary motorized function for the MR system since the identified issue with the HDU does not occur in the motorized mode. If you utilize the manual function and it is not functioning properly, then you must perform table movement using the motorized function.
A Philips Field Service Engineer (FSE) will perform a HDU during the next scheduled preventive maintenance visit. If the issue is detected in the HDU, the Philips FSE will replace the necessary mechanical component(s) to resolve the issue.
If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377) and reference FCO78100527. |
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| Quantity in Commerce | 42 units |
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| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium
Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador,
Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy,
Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan,
Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg,
Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova,
Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan
Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico,
Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia,
Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic,
Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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| 510(K) Database | 510(K)s with Product Code = LNH
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