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Allura Xper FD recallZ-0558-2024 · Philips Medical Systems Nederland B.V. · initiated Nov 3, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it 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

FDA root cause category: Device Design

What the company is doing

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).

Recall details

Recall number
Z-0558-2024
Status
Open, Classified
Initiated by the company
Nov 3, 2023
Posted by the FDA
Dec 15, 2023
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
9991 units
Product code
OWB
FDA submissions
K161563, K162859, K200917
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.

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)

Code information (models, lots, serial numbers)

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).

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93416).

Sources and updates

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