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1688 Camera Control Unit (CCU), Catalog number:1688010000.… recallZ-0728-2022 · Stryker Corporation · initiated Jan 14, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software in the Use Environment

What the company is doing

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 [email protected] 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 [email protected]. 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.

Recall details

Recall number
Z-0728-2022
Status
Open, Classified
Initiated by the company
Jan 14, 2022
Posted by the FDA
Mar 7, 2022
Recalling firm
Stryker Corporation
Quantity
11,955
Product code
GCJ
FDA submissions
K182160
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

Product description

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 (models, lots, serial numbers)

All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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