Recall Z-0979-2015— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2014-12-08, terminated 2015-10-01. It names 4 FDA 510(k) clearances: K060937, K033357, K033326 and 1 more. Product: Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.. Reason: Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-08
- Terminated
- 2015-10-01
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
4 on FDA's record- K060937 — BRILLIANCE VOLUME
- K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271
- K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
- K012009 — MX8000 IDT CT SYSTEM
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
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Reason for recall
Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.