DigitalDiagnost C50

• EUDAMED Basic UDI-DI 0884838BM299TH registered 26 Sep 2022 Active
• FDA 510(k) K201725 decided 10 Jul 2020 Active· +1 more in the status table
• FDA GUDID UDI-DI 00884838095199 listed 4 Sep 2020 Listed

• 2 recalls, same reason

  • Ongoing Z-1383-2023 FDA Class II ·initiated 9 Mar 2023
  • Ongoing Z-1382-2023 FDA Class II ·initiated 9 Mar 2023

  If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users

• • Ongoing Z-1563-2022 FDA Class II ·initiated 25 Feb 2022

  Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

• • Terminated Z-2498-2019 FDA Class II ·initiated 21 Dec 2018

  During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.

1. 4 Jan 2017 Cleared FDA 510(k) K163410
2. 21 Dec 2018 Recall initiated FDA recalls Z-2498-2019
3. 10 Jul 2020 Cleared FDA 510(k) K201725
4. 4 Sep 2020 Listed FDA GUDID 00884838095199
5. 25 Feb 2022 Recall initiated FDA recalls Z-1563-2022
6. 26 Sep 2022 Registered EUDAMED 0884838BM299TH
7. 9 Mar 2023 Recall initiated FDA recalls Z-1383-2023
8. 9 Mar 2023 Recall initiated FDA recalls Z-1382-2023

Generic name

Stationary basic diagnostic x-ray system, digital

Device name

Stationary Digital Radiographic System

Model / Ref / Catalog

DigitalDiagnost C50, 712204

Primary DI / UDI-DI

00884838095199

Basic UDI-DI

0884838BM299TH

Direct marketing DI

00884838095199

510(k) Number

K163410 ↗ 510(k)

K201725 ↗ GUDID

FDA product code

KPR

EMDN code

Z11031101 Multifunctional systems for direct digital radiology

GMDN term

Stationary basic diagnostic x-ray system, digital

Device class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.1680

EU registration type

Standard device

EU market of registration

France

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

GUDID distribution status

Not in Commercial Distribution

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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