Z-0294-2027 Class II Ongoing
Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
— Best
FDA device recall Z-0294-2027 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on Oct 6, 2026 and is designated Class II. Reason for recall: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced… The recall status is ongoing. Affected quantity: 60 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 4, 2026
- Initiation Date
- Oct 6, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product description
Philips Azurion 5 M12. Model Number: 722227.
Reason for recall
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.
Code information
Model Number: 722227. UDI Numbers: (01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)271, (01)00884838099227(21)127, (01)00884838099227(21)128, (01)00884838099227(21)179, (01)00884838099227(21)270, (01)00884838099227(21)246, (01)00884838099227(21)338, (01)00884838099227(21)108, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)104, (01)00884838099227(21)109, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)215, (01)00884838099227(21)213, (01)00884838099227(21)216, (01)00884838099227(21)226, (01)00884838099227(21)83, (01)00884838099227(21)251, (01)00884838099227(21)268, (01)00884838099227(21)309, (01)00884838099227(21)316, (01)00884838099227(21)290, (01)00884838099227(21)310, (01)00884838099227(21)345, (01)00884838099227(21)116, (01)00884838099227(21)153, (01)00884838099227(21)262, (01)00884838099227(21)204, (01)00884838099227(21)113, (01)00884838099227(21)110, (01)00884838099227(21)256, (01)00884838099227(21)308, (01)00884838099227(21)90, (01)00884838099227(21)200, (01)00884838099227(21)362, (01)00884838099227(21)242, (01)00884838099227(21)136, (01)00884838099227(21)95, (01)00884838099227(21)2, (01)00884838099227(21)221, (01)00884838099227(21)165, (01)00884838099227(21)16, (01)00884838099227(21)12, (01)00884838099227(21)257, (01)00884838099227(21)284, (01)00884838099227(21)248, (01)00884838099227(21)26, (01)00884838099227(21)292, (01)00884838099227(21)58, (01)00884838099227(21)130, (01)00884838099227(21)125, (01)00884838099227(21)184, (01)00884838099227(21)57, (01)00884838099227(21)131. Serial Numbers: 135, 88, 271, 127, 128, 179, 270, 246, 338, 108, 305, 356, 346, 313, 104, 109, 337, 306, 215, 213, 216, 226, 83, 251, 268, 309, 316, 290, 310, 345, 116, 153, 262, 204, 113, 110, 256, 308, 90, 200, 362, 242, 136, 95, 2, 221, 165, 16, 12, 257, 284, 248, 26, 292, 58, 130, 125, 184, 57, 131.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0294-2027
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.