| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | July 30, 2021 |
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| Create Date | August 25, 2021 |
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| Recall Status1 |
Terminated 3 on July 25, 2023 |
| Recall Number | Z-2341-2021 |
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| Recall Event ID |
88461 |
| 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 Evoluton- 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 Number: 781315 |
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| Code Information |
S/N and UDI:
US:
61044 (01)00884838099715(21)61044;
61047 (01)00884838099715(21)61047.
OUS:
61028 (01)00884838099715
61008 (01)00884838099715
61025 (01)00884838099715
61026 (01)00884838099715
61034 (01)00884838099715
61035 (01)00884838099715
61042 (01)00884838099715
61046 (01)00884838099715
61040 (01)00884838099715
61041 (01)00884838099715
61018 (01)00884838099715
61017 (01)00884838099715
61032 (01)00884838099715
61043 (01)00884838099715
61033 (01)00884838099715
61064 (01)00884838099715
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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 | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | Philips North America issued U.S. customers letters via certified mail using a 3rd Party service. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall , health risk and action to take:
The Philips Ingenia 1.5T, Ingenia 1.5T Evolution, Ingenia 3.0T, and Ingenia Elition X MR systems can
continue to fulfill clinical use as normal. However, in case of technical problems related to off cooling of the magnet, magnet pressure or Helium boil-off, please stop use and contact your local Philips service representative immediately and reference FCO78100530.
A Philips Field Service Engineer (FSE) will contact you to schedule an on-site visit to resolve the issue by inspecting the potentially affected system(s) to confirm if the non-conforming pressure relief (42 psi) has been installed (reference FCO78100530). If your system has a 42 psi valve, the Phillips FSE will replace the valve with the correct 3.75 psi valve.
you need any further information or support concerning this issue, please contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO78100530.
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| Quantity in Commerce | 2 units US; 16 units OUS |
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| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,
MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria,
Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan,
Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia,
Spain, Turkey, Ukraine, United Kingdom.
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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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = LNH
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