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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Number | Z-1690-2024 |
| Risk Class | Class 2 |
| Recall Qty | 582 |
| Classification Date | 2024-04-18 |
| Recall Link | Recall Link |
| Notes/Alerts | N/A |
| Recall Reason | Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. |
DEVICE
| Manufacturer | Philips North America Llc |
|---|---|
| Model Name | Patient Informaiton system iX - APC 120V UPS and APC 230V UPS |
| Model Number | SCL500RM1U (120V UPS), SCL500RMI1U (230V UPS) |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | UPS for Patient Information Center iX |
| Serial Number(s) | Only serial number date codes prior to 2237* (120V UPS). Only serial number date codes prior to 2241* (230V UPS). |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
1. Philips issued Urgent Medical Device Correction Letter on 3/22/24. Letter states reason for recall, health risk and action to take: If your UPS fails:
2. Promptly take the UPS offline and plug any devices that had been attached to it into a different appropriate power source. Note: It is recommended that UPS devices intended for operation in network and server rooms be kept in a temperature and humidity controlled environment, ensuring adequate airflow around the UPS to prevent UPS device failure.
3. This notice should be passed on to all those who need to be aware within your organization or to any organization where affected devices have been transferred.
4. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will replace the malfunctioning UPS.
5. If you need any further information, please contact your local Philips representative, or call 1-800- 722- 9377. Philips Reference# 2024-CC-HPM-010.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Philips. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787