Z-0728-2022Class II

1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy...

Name: Z-0728-2022 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy...
Creator: Stryker Corporation
Published: 2022-01-14
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2022-01-14 / Open, Classified / root cause: software

FDA source

Stryker Corporation began a recall of 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery... on 2022-01-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0728-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-14
Posted: 2022-03-07
Recalling firm: Stryker Corp.
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: software
FDA root 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 [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.
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
Product codes and lots: All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0728-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0728-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-07

Product code GCJ

K182160Class II1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIMStryker / cleared 2018-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)