Recall Z-0719-2024— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2023-12-07. It names 2 FDA 510(k) clearances: K212441, K180015. Product: Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871. Reason: If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-07
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
2 on FDA's recordK-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
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Reason for recall
If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency.
Data sourced from openFDA. This site is unofficial and independent of the FDA.