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Zenition recallZ-0352-2025 · Philips Medical Systems Nederland B.V. · initiated Oct 7, 2024

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

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

FDA root cause category: Under Investigation by firm

What the company is doing

On October 7, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. 4. Actions that should be taken by the customer! user in order to prevent risks for patients. " Affected systems may continue to be used in accordance with their intended use and Instructions for Use (IFU). " Establish emergency protocols including back up devices if available in place to manage the situation should you experience this issue during the procedure. " Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction with the documentation of the system until Philips implements the correction in your system. Ensure that the letter is in a place likely to be seen! viewed. " If you experience a power loss issue with your system, report the event to Philips. " Complete and return the attached response form (on page 04) to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGT (Image Guided Therapy) systems to correct the problem Philips will replace the 5-Ampere MCU board fuse with a 10-Ampere MCU board fuse in all affected systems. Philips will contact customers to schedule a visit to perform this action free of charge (reference FC071800109). This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax. Be assured that maintaining a high level of safety and quality is our highest priority. If you need additional information or support concerning this issue, contact your local Philips representative at 1800-722-9377 (Philips Customer Care Solutions Center).

Recall details

Recall number
Z-0352-2025
Status
Open, Classified
Initiated by the company
Oct 7, 2024
Posted by the FDA
Nov 12, 2024
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
986 units (156 US, 29 Canada, 801 ROW)
Product code
OWB
FDA submissions
K183101
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Lao People's Democratic Republic, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, R¿union, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, Yemen.

Product description

Philips Zenition 50, Model Number: 718096

Code information (models, lots, serial numbers)

Show the full code information (6k characters)

Model Number: 718096; UDI-DI: (01)00884838091535(21); Serial Numbers: 792, 1762, 1763, 1748, 236, 1310, 1311, 1764, 1078, 1759, 1760, 1761, 317, 1297, 75, 73, 939, 1517, 877, 1857, 50, 1286, 296, 580, 147, 477, 1681, 1288, 875, 1309, 466, 467, 1192, 1369, 386, 387, 52, 51, 1689, 1691, 1692, 1807, 4, 1690, 1693, 415, 1561, 1269, 432, 798, 799, 858, 860, 936, 944, 602, 676, 701, 702, 704, 705, 706, 293, 1895, 703, 859, 862, 863, 1010, 619, 650, 649, 674, 1806, 632, 613, 651, 750, 559, 1030, 886, 486, 487, 1356, 558, 560, 593, 1259, 1703, 1025, 1537, 139, 1206, 1207, 648, 1208, 1110, 372, 1392, 1607, 1248, 1687, 1688, 1686, 1168, 1700, 1232, 1256, 1550, 1068, 814, 1601, 1534, 1800, 1859, 1911, 1390, 975, 1321, 1251, 1673, 1793, 1794, 1795, 1796, 1942, 1249, 1250, 1252, 1253, 1338, 1340, 1342, 1532, 1533, 1684, 345, 400, 401, 402, 615, 617, 618, 768, 769, 770, 771, 772, 773, 774, 775, 620, 1405, 972, 1812, 1339, 1936, 1937, 1938, 1939, 596, 616, 111, 776, 428, 905, 1408, 1355, 1772, 1773, 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Devices named in this recall

1 device 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 95579).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page