FDA Medical Device Recalls (openFDA)
Naviscan PET Systems: Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.
- Recall number
- Z-2229-2008
- Recalling firm
- Naviscan PET Systems
- 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.
- Status
- Terminated
- Initiated
- 2008-06-19
- Posted
- 2008-09-11
- Terminated
- 2009-03-13
- Reason
- 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
- 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
- 13
- Distribution
- Nationwide to CA, FL, MA, MO, NY, OK, PA, TX, and WA
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K032063"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 3005945241
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28