PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 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)

Recall number

Z-0558-2024

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

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)

Status

Open, Classified

Initiated

2023-11-03

Posted

2023-12-15

Terminated

not on file

Reason

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

Root cause

Device Design

Action

Philips issued Urgent Medical Device Correction (UMDC) letter US customers in the US on 11/3/23 and a Field Safety Notice (FSN) to customers outside the US. Letter states reason for recall, health risk and action to take: As a remedy, Philips is replacing the existing covers of all the affected Philips Allura and Philips Azurion with the monoplane fixed ceiling mounted systems with a redesigned L-arm rotation cover (bolted instead of spring clips) to make sure it is resistant to external collisions. Philips will contact all affected customers to arrange for a Field Service Engineer visit to replace the Larm rotation cover free of charge (reference FCO72200510 for the Philips Allura systems including the Philips Poly G H5000, FCO72200511 for the Philips Azurion systems). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

Quantity

9991 units

Distribution

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.

Lot, serial or model codes

Model/Name/UDI-DI: 722001 Allura Xper FD10C; 722003 Allura Xper FD10; 722006 Allura Xper FD20 (01)00884838059115(21); 722010 Allura Xper FD10 (01)00884838059030(21); 722012 Allura Xper FD20 (01)00884838059054(21); 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 (01)00884838059085(21;) 722026 Allura Xper FD10 (01)00884838054189(21); 722028 Allura Xper FD20 (01)00884838054202(21); 722035 Allura Xper FD20 OR Table (01)00884838054240(21); 722043 Integris Allura 15 & 12 (monoplane).

510(k) numbers

["K161563","K162859","K200917"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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