Z-0277-2024Class II
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images
Philips North America LLC / initiated 2023-09-21 / Open, Classified
Philips North America Llc began a recall of DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images on . FDA classified it as Class II and gives the reason as "Potential for units suspended on the ceiling to fail and fall". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0277-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
- Product code
- JAA System, X-Ray, Fluoroscopic, Image-Intensified
- Reason for recall
- Potential for units suspended on the ceiling to fail and fall.
- FDA root cause
- Under Investigation by firm
- Action
- 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 [email protected]. 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.
- Quantity in commerce
- 1 unit
- Distribution
- Nationwide distribution.
- Product codes and lots
- Model No. 712025; Serial No. SN13000328.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0271-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0272-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0273-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0274-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0275-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0276-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0277-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0278-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0279-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0280-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.