MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Summary
The FDA issued a Class II for MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgra by Philips North America. Reason: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system..
Details
Source
Device Recall
External ID
Z-2397-2023
Action Date
2023-08-16
Status
Ongoing
Category
device
Product Description
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Lot/Code Info: Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 65008 65007 65006 65005 65004 65003 65002 65000 65020 65012 65034 65001; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 45301 45298 45007 45297 45557
Quantity Affected: 640 total
Reason for Recall
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Distribution
US Nationwide. Global Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-12
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America has 126 FDA actions in our database, including 126 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America have FDA actions?
Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2397-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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