CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report
SmartPath to dStream for 5T recalled by Philips North America
Philips North America is recalling SmartPath to dStream for 5T, distributed nationwide in the US. The recall was initiated on 3 Jan 2024 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-0955-2024
- FDA event ID
- 93787
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jan 2024
- FDA classified
- 1 Feb 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Jan 2024 | Recall initiated by company | |
| 1 Feb 2024 | Classified by FDA | +29 days |
| 7 Feb 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is SmartPath to dStream for 5T recalled?
Yes. Philips North America recalled SmartPath to dStream for 5T on 3 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-0955-2024.
Why was it recalled?
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Which lots are affected?
a. Model No. 781260; UDI-DI 00884838095076. b. Model No. 782112; UDI-DI 00884838098886. All units affected
Where was it sold?
Worldwide - 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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