Class 2 Device Recall Camera Control Unit (CCU)

• Date Initiated by Firm: January 14, 2022
• Date Posted: March 07, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0728-2022
• Recall Event ID: 89515
• 510(K)Number: K182160
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
• Code Information: All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18
• Recalling Firm/ Manufacturer: Stryker Corporation; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Michael Hilldoerfer; 408-754-2000
• Manufacturer Reason for Recall: A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.
• FDA Determined Cause: Software in the Use Environment
• Action: Medical Safety Notification was issued On January 28, 2022. This is Part 1 of 2. Customer Instructions on January 28,2022 state: Check inventory to see if you have a 1688 Pendulum Camera. NO PRODUCT RETURN IS NECESSARY. Return the business reply form by email to endorecall@stryker.com to confirm receipt of this notification. Maintain awareness of this communication internally until part 2 of 2 of this field action is conducted. If you have any questions or concerns, please email endorecall@stryker.com. These solutions are temporary while Stryker Endoscopy develops a software update to the 1688 Camera Control Unit to solve this issue. Part 2 of the field action will be a software update on all 1688 CCUs, which Stryker will install. Temporary Solutions: a) Preventing the Flip: 1. The only way to prevent the possibility of the image flip is to remove the USB A-to-B Cable from the CCU to Hub. However, this will cause the loss of device control through the CCU. b) Methods to Avoid/Correct Flip: 1. Do not select "End Case" on the Hub while a camera head is inserted. 2. If the flip does occur, unplugging and re-plugging the camera head will resolve the issue. However, this is only temporary, and this may occur again if "End Case" is selected Recall notices dated May 6, 2022, were distributed to all customers with 1688 Camera Control Units. Customers were asked to check their inventory and if affected product is found, call their Sales Representative or OnSite Specialist to upgrade CCU Software. Complete and return the customer acknowledgment form. Please use Temporary Solutions (section above) until software upgrade is complete. The software version can be found on the bottom right corner of the screen during boot up.
• Quantity in Commerce: 11,955
• Distribution: Worldwide distribution. US nationwide including Puerto Rico. OUS: BR, AE, NL, IN, FR, ES, HK, IT, GB, CO, PE, MY, TH, CA, JP, MX, AR, NP, SG, PH, ZA, CL, KR, CN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GCJ