Recall record at a glance
| Official record | Z-0558-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Report date | Dec 27, 2023 |
| Recall initiation date | Nov 3, 2023 |
| Quantity | 9991 units |
| Location | Best, N/A, Netherlands |
Official product description
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722026 Allura Xper FD10 722028 Allura Xper FD20 722033 Allura Xper FD10 OR Table 722035 Allura Xper FD20 OR Table 722043 Integris Allura 15 & 12 (monoplane) 72246 Poly G - OMCP - VISUB - CCD (H5000)
Why the product was recalled
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
Distribution information
Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Latvia, Republic of Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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