Stryker Medical Epic II Critical Care Bed, 115 V, Stryker Medical, Portage, MI.; Model 2030.
FDA device recall Z-1686-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Stryker Medical Div. of Stryker Corporation
- Reason for recall
- The brakes may not have adequate holding power to lock the bed in place.
- Action taken
- Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FNL
- Quantity affected
- 66,558 of all models.
- Distribution
- Worldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom.
- Date initiated
- 2008-02-01
- Date posted
- 2008-09-19
- Date terminated
- 2010-11-05
- Location
- Portage, MI
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