Z-0216-2020Class I

Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of...

Name: Z-0216-2020 Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2019-09-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-09-19 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the... on 2019-09-19. FDA classified it as Class I and gives the reason as "An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit". 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-0216-2020
Classification: Class I
Status: Terminated
Initiated: 2019-09-19
Posted: 2019-11-01
Terminated: 2021-04-05
Recalling firm: Philips North America LLC
Product: Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On September 19, 2019 the firm distributed Urgent Field Safety Notice (FSN) Medical Device Correction letters by direct communication from Philips Field Service Engineers instructing them to: - Discontinue system use until further notice - Inform those who need to be aware within your organization or any organization where the potentially affected devices have been transferred (If appropriate). - Maintain this notice with your system Instructions for Use (IFU) until the correction is made to the system. ACTIONS PLANNED BY PHILIPS: Philips Healthcare is distributing this FSN to all affected customers/users and will deploy a solution addressing the issue upon completion of the investigation. FURTHER INFORMATION AND SUPPORT: If you need any further information or support concerning this issue, please contact your local Philips representative: For SUPPORT in North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Quantity in commerce: 1167 in total
Distribution: Nationwide Distribution.
Product codes and lots: System Code: 889456 System Serial Number: 24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0216-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0213-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01
Z-0214-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01
Z-0215-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01
Z-0216-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01
Z-0217-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01

Product code KPS

K982911Class IIForteAdac Laboratories / cleared 1998-11-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)