Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.

Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.

On February 26, 2021 Stryker sent a "Urgent Medical Device Recall notification via mail to all affected consignees. In addition, to informing consignees about the reason for a recall, the firm ask consignees to take the following actions: 1. Immediately check inventory to locate the product listed on Attachment A and remove them from their point of use. 2. Return the enclosed business reply form by email to [email protected] to confirm receipt of this notification/document product segregation. RESPONSE IS REQUIRED. a. If affected product is found, segregate the product and call Stryker customer service at 1-800-624-4422 (Option 3) or email [email protected] to arrange for product return and receive a replacement (upon availability) and complete Business Reply form, Attachment B on page 3. b. If no product is found, complete Business Reply form, Attachment B on page 3 of this recall letter. 3. Maintain awareness of this communication internally until all required actions have been completed. 4. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. If you have any questions or concerns, please email [email protected].