Z-0280-2022Class II

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470...

Name: Z-0280-2022 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470...
Creator: Philips North America Llc
Published: 2021-05-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-05-01 / Open, Classified / root cause: design

FDA source

Philips North America Llc began a recall of Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that... on 2021-05-01. FDA classified it as Class II and gives the reason as "Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0280-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-01
Posted: 2021-11-24
Recalling firm: Philips North America LLC
Product: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part
Root cause tag: design
FDA root cause: Device Design
Action: Philips notified U.S. consignees by "URGENT - Field Safety Notice Medical Device Correction" FSN 72800751 for CT consignees and FSN 88200530 for PET/CT consignees via USPS Certified mail on 5/1/21. Non-U.S. customers will receive the letter through Philips Global Markets following local regulations. Letter states reason for recall, health risk and action to take: Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm. " Inspect the joint area of your CCT DVI Ceiling Mount Arm (the circled area in picture at the right) and observe that the safety clip is installed (as depicted in pictures below). " When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm. When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions: stop using the suspension monitor clinically move the monitor arm away from any person call Philips Service for repairs. Please acknowledge the receipt of this notice by completing, signing, and returning the form to the indicated email address: [email protected]. Philips is inspecting the affected units and, if necessary, repairing joint safety components and joint wear components by FCO 72800751 and FCO 72800752 for CT consignees, and FCO 88200530 and FCO 88200531 for AMI consignees, respectively. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Quantity in commerce: 3 units
Distribution: US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia.
Product codes and lots: Serial Number: 7084 7145 7584

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0280-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0277-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-23
Z-0278-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-23
Z-0279-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-23
Z-0280-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-23
Z-0281-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-23

Product code KPS

K051170Class IIGemini GxlPhilips Medical Systems (Cleveland), Inc. / cleared 2005-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)