Incisive CT systems with ECG cable risk of signal loss
Philips Incisive CT systems with specific ECG cable may experience signal loss due to connector weakness, potentially delaying diagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic imaging device where cable connector weakness may cause intermittent ECG signal loss, potentially delaying diagnosis in clinical emergencies. With no reported injuries or hospitalizations, it meets the criterion for High severity: a risk-of-harm product without reported injury.
Plain-English summary
Philips is recalling certain Incisive CT computed tomography systems (Models 728144 and 728143) that include a specific Patient Interface Monitor (PIM) cable with part number 459801179871. The recall affects 55 systems in the United States and 1,029 systems distributed internationally.
The PIM cable connector and wire may disconnect from the weld point if the cable is repeatedly plugged and unplugged during normal daily use. When disconnection occurs, the system may experience intermittent loss of the ECG signal that monitors the patient's heart rhythm.
Loss of ECG signal may lead clinicians to rescan the patient or delay diagnosis during a medical emergency. No illnesses or injuries have been reported.
To determine if your Incisive CT system is affected, locate the connection cable between the ECG monitor and the CT gantry and verify that the PIM cable part number matches 459801179871. Affected serial numbers for both models are documented in the FDA recall notice.
The recalled product
- Product
- Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
- Manufacturer
- Philips North America
Distribution
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