CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report
Uniq Product Usage: Vascular,cardiovascular recalled
Philips Healthcare is recalling Uniq Product Usage: Vascular,cardiovascular and neurovascular imaging, distributed nationwide in the US. The recall was initiated on 11 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2499-2018
- FDA event ID
- 80402
- Recalling firm
- Philips Healthcare, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jun 2018
- FDA classified
- 24 Jul 2018
- Reported
- 1 Aug 2018
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 11 Jun 2018 | Recall initiated by company | |
| 24 Jul 2018 | Classified by FDA | +43 days |
| 1 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UNIQ 1.0.10 UNIQ 1.0.10.5
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 80402This product is part of a recall event; the main page for the event is Centron Product Usage: Vascular,cardiovascular and neurovascular recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centron Product Usage: Vascular,cardiovascular and neurovascular recalled | Philips Healthcare | Other | Nationwide | |
| CLASS II | Allura Xper recalled by Philips Healthcare | Philips Healthcare | Other | Nationwide |
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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
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| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |