Stryker Recalls Spirit Select and Plus Hospital Beds Due to Actuator Failure
Stryker Medical is voluntarily recalling Spirit Select and Spirit Plus hospital beds because broken actuators may cause the bed to lower unexpectedly, risking patient injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential for patient injury.
Plain-English summary
Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds. The recall is due to reports of hi-lo actuators breaking at the mount ends. This defect could cause the bed to lower unexpectedly, resulting in patient injury.
The recall affects 4,308 units of the Spirit Select Bed, Model 5700, manufactured between November 1, 2014, and January 13, 2016. The affected serial numbers range from 029481 to 032097, with specific gaps in the sequence. The units were distributed nationwide in the United States and in Canada.
Healthcare facilities and consumers should check their inventory for these specific model and serial numbers. If a bed is affected, it should be removed from service to prevent potential injury to patients.
The recalled product
- Product
- Spirit Select Bed, A-C Powered Hospital Bed
- Manufacturer
- CHG Hospital Beds Inc
- Category
- Medical Device — Hospital Bed
- Affected units
- 4,308
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 (4)
- Model Numbers: 5700
- Spirit Select Bed (manufactured between November 1
- 2014 January 13
- 2016)
Distribution
Part of a larger recall action
This product is one of 2 recalled by CHG Hospital Beds Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · CHG Hospital Beds Inc
See all →- HighStryker Recalls Spirit Plus Hospital Beds Due to Actuator Failure
FDA (Devices) · 2016-08-10
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