Z-2109-2016Class II

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

Name: Z-2109-2016 Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-06-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-06-14 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2016-06-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2109-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-14
Posted: 2016-06-30
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: 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
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Medical Systems (Cleveland), Inc. sent a Customer Information letter dated June 14, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. No action is required of the customer for this issue. Systems that may have been manufactured with these stainless steel fasteners still meet the safety specifications required for the adjustment cradle and may continue to be used clinically. For further information or support customers were instructed to call 1-800-722-9377. For questions regarding this recall call 404-483-2015.
Quantity in commerce: 47 units
Distribution: Worldwide distribution to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and United Kingdom
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2109-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2110-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30

Product code JAK

K033357Class IIAcqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. / cleared 2004-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)