Recall Z-1584-2023— Philips North America Llc

Name: FDA recall Z-1584-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-17

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-03-17. It names one FDA 510(k) clearance: K203020. Product: Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333. Reason: Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-03-17
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K203020 — Spectral CTPhilips Medical Systems Nederland B.V.·cleared 2021-02-26

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

Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

Reason for recall

Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

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