Recall Z-0569-2015— Stryker Endoscopy
Class II · Terminated
Class II FDA medical device recall by Stryker Endoscopy, initiated 2013-03-05, terminated 2014-12-10. It names one FDA 510(k) clearance: K132785. Product: 1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.. Reason: In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period.
- Recalling firm
- Stryker Endoscopy
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-05
- Terminated
- 2014-12-10
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
Reason for recall
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Data sourced from openFDA. This site is unofficial and independent of the FDA.