Z-1088-2024 Class II Ongoing
FDA device recall Z-1088-2024 was initiated by PHILIPS MEDICAL SYSTEMS on February 11, 2022 and is designated Class II. 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 di… The recall status is ongoing. Affected quantity: 130 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- February 11, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 units
Product Description
CombiDiagnost R90 1.1 (709031)
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.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
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;