FDA Medical devices recall ·
CombiDiagnost R90 recall
- Recall number
- Z-0462-2026
- Date
- (initiated October 1, 2025)
- Company / brand
- Philips Medical Systems DMC GmbH
Development And Manufacturing Ctr., Hamburg, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 17 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CombiDiagnost R90; Model Number: 709031;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 709031; UDI-DI: 00884838101456; Serial Number: 100001385, 100001402, 100001409, 100001412, 100001415, 100001416, 100001417, 100001424, 100001426, 100001432, 100001449, 100001460, 100001464, 100001476, 100001480, 100001483, 100001488;
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.,
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0462-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.