The Recall Desk
HighFDA (Devices)·Z-0513-2018·Announced 2018-02-14

Philips Precedence 6 Imaging System Recalled for Collimator Drop Risk

Philips is recalling 1,387 Precedence 6 imaging systems because collimators may drop to the floor during exchange, posing a risk of injury.

What this means for you

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 equipment dropping) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 1,387 Precedence 6 Model # 882351 imaging systems. These systems combine single photon nuclear medicine and x-ray computed tomography imaging and are used by trained healthcare professionals.

The recall is due to a mechanical issue 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 or slide completely to the floor, or it may be partially supported by the cart while leaning against it.

The affected units were distributed worldwide and across the United States. Healthcare facilities should contact Philips Medical Systems for instructions on how to address this issue.

The recalled product

Product
Precedence 6 Model # 882351 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 attenua
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.

See all 5 products in this recall →