FDA Medical devices recall ·
Allura Xper CV20 recall
- Recall number
- Z-0014-2026
- Date
- (initiated September 3, 2025)
- Company / brand
- Philips Medical Systems Nederland B.V.
Veenpluis 4-6, Best, N/A, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 53 units (OUS only)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Why was it recalled?
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
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 Numbers: 722031; UDI-DI: N/A; Serial Numbers: 29, 77, 23, 18, 45, 90, 164, 30, 76, 32, 75, 33, 40, 13, 113, 111, 46, 25, 130, 26, 61, 78, 42, 167, 49, 64, 41, 71, 20, 17, 63, 39, 9, 55, 36, 73, 48, 53, 31, 96, 28, 154, 166, 15, 84, 47, 35, 24, 148, 50, 79, 62, 66;
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
States: Georgia
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-0014-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.