Stryker Camera Control Unit Recalled Due to Inverted Image Display Defect
Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall with no reported injuries or hospitalizations. The defect creates a theoretical risk of serious surgical complications through image inversion during procedures. Per the rubric, recalls with no reported illness and theoretical hazards score at most 3, placing this in the High category.
Plain-English summary
Stryker Corporation is recalling the 1688 Camera Control Unit (CCU), Catalog number 1688010000. This device is used in laparoscopic, endoscopic, and arthroscopic surgical procedures worldwide, including throughout the United States and Puerto Rico.
A software defect in the camera control unit causes the monitor image to display upside-down and in an incorrect orientation during use. This image inversion could cause surgeons to misidentify anatomical landmarks or tissue locations, potentially leading to surgical complications.
The potential harms associated with this defect include conversion to open surgery, additional medical interventions, or revision surgery. Approximately 11,955 units have been distributed globally. The defect affects software revisions 3.0.6, 4.0.13, and 4.0.18. Facilities and surgeons should contact Stryker immediately for repair or replacement options.
No injuries or illnesses have been reported in connection with this defect.
The recalled product
- 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.
- Manufacturer
- Stryker Corporation
- Affected units
- 11,955
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- All serial numbers of 1688 CCU
- UDI: 07613327420081
- with Software Revisions: 3.0.6
- 4.0.13
- and 4.0.18
Distribution
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