Incisive CT — Class II medical device recall Z-0719-2024
Ongoing recall by Philips North America, reported 2024-01-24, distributed in AL, CA, CO, FL, GA, HI, IL, IN…. If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the c
| Recall number | Z-0719-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-12-07 |
| Classified | 2024-01-12 |
| Reported by FDA | 2024-01-24 |
| Distributed | AL, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MI, MO, MS, ND, NE, NJ, NY, OH, OK, PA, RI, SC, TX, UT, VT, WA |
| UPC / GTIN / UDI-DI | 00459801179871, 00884838085015, 00884838105508 |
| Serial numbers | 33001, 33002, 33003, 33005, 33006, 33007, 33009, 33010, 33011, 33012, 33013, 33015, 33019, 33020, 33024, 33031, 33033, 33034, 33035, 33037, 33038, 33041, 33045, 33046, 33047 and 29 more |
| Model numbers | 459801179871, 728143, 728144 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0719-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.