FDA Medical Device Recalls (openFDA)
Philips Medical Systems: SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
- Recall number
- Z-0398-2011
- Recalling firm
- Philips Medical Systems
- Product
- SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
- Status
- Terminated
- Initiated
- 2010-10-15
- Posted
- 2010-11-17
- Terminated
- 2012-03-21
- Reason
- Detector arm assembly may slide to hardware limit, potentially causing impact.
- Root cause
- Component change control
- Action
- Firm will notify consignees via Urgent - Medical Device Correction, dated Nov 3, 2010, via FedEx. The letter identified the affected product, described the problem, the hazard involved, how to identify affected products, actions to be taken, and actions planned by Philips. Customers are to contact their Field Safety Engineer immediately to schedule an inspection of their system. If customers suspect that the identified problem has occurred with their device, they should immediately stop using the system until Philips has confirmed it as safe to use. If customers need further information concerning this issue, they are to contact their local Philips representative.
- Quantity
- 24 units
- Distribution
- Worldwide Distribution -- USA and the Netherlands.
- Lot, serial or model codes
- 3/8" SPECT, Model number 4535 600 66661, and 5/8 SPECT, Model number 4535 602 20381, all units manufactured between July 2001 to August 2003.
- 510(k) numbers
- ["K000908"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- San Jose
- 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