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CombiDiagnost R90 recallZ-1088-2024 · Philips Medical Systems · initiated Feb 11, 2022

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 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

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 root cause category: Software design

What the company is doing

An 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.

Recall details

Recall number
Z-1088-2024
Status
Open, Classified
Initiated by the company
Feb 11, 2022
Posted by the FDA
Feb 14, 2024
Recalling firm
Philips Medical Systems
Quantity
130 units
Product code
JAA
FDA submissions
K203087
Distribution
US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.

Product description

CombiDiagnost R90 1.1 (709031)

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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;

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 93819).

Sources and updates

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