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U.S. Department of Health and Human Services

Class 2 Device Recall Philips CombiDiagnost R90

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 Class 2 Device Recall Philips CombiDiagnost R90see related information
Date Initiated by FirmFebruary 11, 2022
Date PostedFebruary 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1088-2024
Recall Event ID 93819
510(K)NumberK203087 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductCombiDiagnost R90 1.1 (709031)
Code Information Model: R90 1.1 (709031); UDI DI: 00884838101456; Software version 1.1.1 or higher; Serial Numbers: 10001004, 10001005, 10001006, 10001008, 10001009, 10001010, 10001011, 10001012, 10001013, 10001018, 10001020, 10001022, 10001024, 10001026, 10001027, 10001028, 10001029, 10001030, 10001031, 10001032, 10001035, 10001036, 10001043, 10001044, 10001045, 10001046, 10001047, 10001048, 10001049, 10001050, 10001051, 10001052, 10001053, 10001054, 10001055, 10001056, 10001057, 10001058, 10001059, 10001060, 10001061, 10001062, 10001063, 10001064, 10001065, 10001066, 10001067, 10001068, 10001069, 10001070, 10001071, 10001072, 10001073, 10001074, 10001075, 10001076, 10001077, 10001078, 10001079, 10001080, 10001081, 10001083, 10001084, 10001085, 10001086, 10001087, 10001088, 10001089, 10001090, 10001091, 10001092, 10001093, 10001094, 10001095, 10001096, 10001097, 10001098, 10001099, 10001100, 10001101, 10001102, 10001103, 10001104, 10001105, 10001106, 10001107, 10001108, 10001109, 10001110, 10001111, 10001112, 10001113, 10001114, 10001115, 10001116, 10001117, 10001118, 10001119, 10001120, 10001121, 10001122, 10001123, 10001124, 10001125, 10001126, 10001127, 10001128, 10001129, 10001130, 10001131, 10001132, 10001133, 10001134, 10001135, 10001136, 10001137, 10001138, 10001139, 10001140, 10001141, 10001142, 10001143, 10001144, 10001145, 10001147, 10001148, 10001149, 10001150, 10001152, 10001201;
Recalling Firm/
Manufacturer
PHILIPS MEDICAL SYSTEMS
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactCustomer Care Solution Center
1800-722-9377
Manufacturer Reason
for Recall
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
FDA Determined
Cause 2
Software design
ActionAn Important Product Notice (2021-PD-DXR-034) dated February 15, 2022 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to follow the provided instructions to ensure there are no pending images before an exam circulate the notice to all users and to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.
Quantity in Commerce130 units
DistributionUS Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAA
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