Philips Precedence 16 Imaging System Recalled for Collimator Drop Risk
Philips is recalling 1,387 Precedence 16 imaging systems because collimators may drop to the floor during exchange, posing a physical hazard.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (heavy medical equipment dropping) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,387 Precedence 16 Model # 882350 imaging systems. These systems combine single photon nuclear medicine imaging and x-ray computed tomography and are used by trained healthcare professionals to produce diagnostic images.
The recall is due to a mechanical issue that can occur during collimator exchange. The alignment of the collimator cart and detectors may cause the exchange to fail, resulting in the collimator dropping to the floor beside the cart. The collimator may fall completely to the floor or remain partially supported by leaning against the cart.
The affected units were distributed worldwide and nationwide in the US. Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect and ensure the safety of their staff and patients.
The recalled product
- Product
- Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — Imaging System
- Affected units
- 1,387
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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