Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108)...
Stryker Communications began a recall of Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); Distributed by Stryker Communications, Flower Mound, TX... on . The reason FDA records is "Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0303-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- STRYKER Communications, Inc.
- Product
- Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)
- Product code
- GCJ Laparoscope, General & Plastic Surgery
- Reason for recall
- Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Firm notified consignees of recall via letter (Urgent Device Recall) on 09/21/07. Consignees were notified that a customer service representative would visit each facility to replace out-of-spec cables with properly shielded cables at no charge.
- Quantity in commerce
- 1,653 cables.
- Distribution
- Worldwide: USA and Australia, Belgium, Canada, France, Germany, Great Britain, Hong Kong, Japan, Korea, Mexico, Netherlands, New Zealand, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, and The U.A.E.
- Product codes and lots
- All Lots and Serial Numbers shipped between Oct. 2006 and June 2007.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
