FDA Device Recall Z-0278-2024: Philips North America Llc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0278-2024.

Recall Res Number

Z-0278-2024

Recalling Firm / Manufacturer

Philips North America Llc

FEI Number

3016618143

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-09-21

Date Posted

2023-11-08

Date Terminated

N/A

Product Code

JAA

Event Number

93200

Product Quantity

2 units

Product Description DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.

Reason for Recall Potential for units suspended on the ceiling to fail and fall.

Action Details The firm distributed recall notifications dated 8/31/2023 via FedEx to affected consignees. Consignees are instructed to immediately stop use of affected devices and contact their local Philips service representative if the Ceiling Suspension becomes unstable, if moving the Ceiling Suspended X-Ray Tube requires a high amount of force, or if moving the Ceiling Suspended X-Ray Tube is noticeably hampered. The recall notice is to be circulated among all device users, so they are aware of this issue and placed as an addendum in the IFU. Consignees are to complete the provided response form and return it to Philips no later than 30 days from notification receipt via email to pd.cnr@philips.com. Philips will contact consignees to schedule a time for a Field Service Engineer to visit customer sites to inspect affected systems and correct the issue. Consignees with any questions are to contact the Customer Care Solutions Center at 1-800-722-9377.

Distribution Pattern Nationwide distribution.

Code Information / Serial Numbers Model No. 712026; Serial No. SN14000197 & SN14000260.

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Medical Device Recall: Z-0278-2024

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer