1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscop
Summary
The FDA issued a Class II for 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general lapa by Stryker Corporation. Reason: 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 potentia.
Details
Source
Device Recall
External ID
Z-0728-2022
Action Date
2022-03-16
Status
Ongoing
Category
device
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.
Lot/Code Info: All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18
Quantity Affected: 11,955
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-14
Company
San Jose, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0728-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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