UNIQ Product Usage: Vascular — Class II medical device recall Z-2499-2018
Terminated recall by Philips Healthcare, reported 2018-08-01, distributed nationwide. The first time an operator selects a new procedure type during a single examination,the shutter position reset
| Recall number | Z-2499-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Healthcare, Andover, MA, United States |
| Recall initiated | 2018-06-11 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2024-07-03 |
| Distributed | Nationwide (US) |
| Quantity | 459 affected |
Product
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.
Reason for recall
The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
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-2499-2018. 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.