Z-1506-2016Class II

IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH...

Name: Z-1506-2016 IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-03-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-03-04 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process... on 2016-03-04. FDA classified it as Class II and gives the reason as "The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 relative to one another. However, certain gamma cameras allow for other relative detector...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1506-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-04
Posted: 2016-04-15
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
Root cause tag: software
FDA root cause: Software design
Action: On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips representative.
Quantity in commerce: 33 Units
Distribution: Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.
Product codes and lots: M/N 881001; S/N: 85254, 82202, 85330, 82117, 7000022, 105009, 970001, 850001, 870030, 82141, 95068, 87182, 87197, 95078, 82140, 11017, 98139, 95035, 87200, 980047, 85314, 85303, 980046, 85298, 822022, 7000019, 950076, 950115, 95043, 95047, 950021, 960123 & 105006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1504-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-15
Z-1505-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-15
Z-1506-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-15

Product code JAK

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)