Reported Jan 24, 2024 · Ongoing
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Philips North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
- Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
- Lot codes and dates
- Incisive CT systems configured with the PIM cable option are affected by this issue. To determine whether your system is affected, please locate the connection cable between your ECG monitor and incisive CT gantry and verify that the part number on your PIM cable matches 459801179871 . (1) REF 728143 -
- UDI-DI 00884838085015 Serial Numbers(2) REF 728144 -
33007330383301333006330123304533011500102330153300533041330475002175002553303550025250014550004650016833009330463302450022250006433034500242500301330103301933001330203303133037500110500111500178330035002823300233033
- UDI-DI 00884838105508 Serial Numbers
3400234051340503404134059340573405434040340073402634058340493405634052
- Amount recalled
- 55 US; 1029 ROW
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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