Recall Z-1563-2022— Philips North America Llc

Name: FDA recall Z-1563-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-25

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2022-02-25. It names 2 FDA 510(k) clearances: K201725, K163410. Product: DigitalDiagnost C50 1.1. Reason: 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2022-02-25
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K201725 — DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit.·cleared 2020-07-10
K163410 — DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd.·cleared 2017-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DigitalDiagnost C50 1.1

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.