Summary
The FDA issued a Class II for Allura Xper series by Philips Medical Systems Nederland B.V.. Reason: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Details
Source
Device Recall
External ID
Z-2402-2023
Action Date
2023-09-13
Status
Ongoing
Category
device
Product Description
Allura Xper series
Lot/Code Info: Allura Xper series
Quantity Affected: 5432 systems in total
Reason for Recall
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2023-07-19
Company
Eindhoven, N/A
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 148 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Philips Medical Systems Nederland B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
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 Medical Systems Nederland B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Medical Systems Nederland B.V. have FDA actions?
Philips Medical Systems Nederland B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2402-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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