Z-2229-2008

Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body...

Name: Z-2229-2008 Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body...
Creator: Naviscan PET Systems
Published: 2008-06-19
License: https://open.fda.gov/license/

CMR Naviscan Corporation / initiated 2008-06-19 / Terminated / root cause: design

FDA source

Naviscan PET Systems began a recall of Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology on 2008-06-19. The reason FDA records is "This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2229-2008
Status: Terminated
Initiated: 2008-06-19
Posted: 2008-09-11
Terminated: 2009-03-13
Recalling firm: CMR Naviscan Corporation
Product: Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan positioning of the patient. The investigation identified that a secondary fault protection did not perform as expected.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Field Correction Notice was sent to all PEM Flex Solo II customers about this issue via Federal Express Priority Service on June 19, 2008. Customers were informed of the: (1) Issue: Potential for motorized compression to exceed 25 pounds of compression force if continued beyond the primary safety limit, This could lead, to patient discomfort or injury. (2) Advisory: Naviscan recommends that patient breast positioning be completed by ceasing motorized-compression when the primary safety limit of 15 pounds pre-compression force is reached. This is indicated by the automatic stopping of the paddle movement as controlled by the primary safety system. "Fine-tuning" positioning, should be completed by using the manual adjustment knobs. (3) Correction: A Naviscan Field Service Engineer will contact each customer to schedule a field correction visit. If customers have any questions they were instructed to contact Naviscan Customer Support at 1-888-628-4159.
Quantity in commerce: 13
Distribution: Nationwide to CA, FL, MA, MO, NY, OK, PA, TX, and WA
Product codes and lots: Serial Numbers: P002-B-070316-01, P002-B-070423-01, P002-B-070531-01, P002-B-070629-01, P002-B-070712-0l, P002-B-070718-01, P002-B-070910-01, P002-B-070911-01, P002-B-071015-01, P002-B-080107-01, P002-B-080108-01, P002-B-080207-01, and P002-B-080307-01

Product code KPS

K032063Class IIPem 2400 Pet ScannerPem Technologies / cleared 2003-08-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)