Recall Z-1428-2021 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Corporation
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.
| Date | Feb 26, 2021 |
| Status | Terminated |
| Reason | Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots. |
| Root cause | Component design/selection |
| Action | 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 endorecall@stryker.com to confirm receipt of this notification/document product segregation. RESPONSE IS REQUIRED. a. If affected product is found, segregate the product and call Stryke |
| Quantity | 125 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IL, MA MI, MS NC, NV, OK, PA, SC, TN, TX, VA, WA, WI and the countries of AE, CA, CN, CZ, DE, ES, HK, JP, KR, KW, MX, MY, PH, RO, SG, TR, TW. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150956 | PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies, Inc., May 23, 2016 |