Reported Jul 6, 2016 · Terminated

Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body…

Philips Medical Systems (Cleveland) Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131

Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes

Lot codes and dates: Big Bore Oncology System Code 728243
Serial numbers
75002
75003
75004
75005
75006
75007
75008
75009
75010
75011
75012
75014
75015
75016
75017
75018
75019
75020
75021
75022
75023
75024
75025
75026
75030
75032
75035
75036
75037
75040
75042
75044
75047
75048
75049
75051
75053
75060
75064
75100
75102
75104
75105
750111
750114
Amount recalled: 47 units

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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89 in total.