Summary
The FDA issued a Class II for ProxiDiagnost N90; Model Number: 706110; by Philips Medical Systems DMC GmbH. Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move verti.
Details
Source
Device Recall
External ID
Z-0461-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
Product Description
ProxiDiagnost N90; Model Number: 706110;
Lot/Code Info: Model Number: 706110; UDI-DI: 00884838103221; Serial Number: 10001185, 10001205, 10001220, 10001224, 10001225, 10001227, 10001228, 10001229, 10001230, 10001231, 10001234, 10001235, 10001236, 10001237, 10001239, 10001245, 10001247, 10001248, 10001249, 10001250, 10001251, 10001253, 10001256, 10001257, 10001258, 10001261, 10001262, 10001264, 10001265, 10001266, 10001269, 10001270, 10001271, 10001272, 10001273, 10001274, 10001275, 10001276, 10001277, 10001278, 10001282;
Quantity Affected: 41 units
Reason for Recall
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Distribution
Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-01
Company
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 403 device-related FDA actions this month.
Philips Medical Systems DMC GmbH has 15 FDA actions in our database, including 11 recalls and 4 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 DMC GmbH) 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 DMC GmbH have FDA actions?
Philips Medical Systems DMC GmbH has 15 FDA actions in our database, including 11 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0461-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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