ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Summary
The FDA issued a Class II for ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. by Stryker Medical Division of Stryker Corporation. Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock..
Details
Source
Device Recall
External ID
Z-0435-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Lot/Code Info: UDI-DI (GTIN): 07613327541328. Serial numbers: 2209001834, 2209001941 , 2209001939 , 2211002329 , 2211002319 , 2211000556 , 2205000776 , 2106000019 , 2202002062 , 2106001528 , 2106001515 , 2209001539 , 2203000249 , 2106002482 , 2202001091 , 2203000298 , 2203000098 , 2108000232 , 2208000679 , 2110000200 , 2106002061 , 2106002051 , 2106001697 , 2211004469 , 2211004828 , 2206001229 , 2206001234 , 2211004824 , 2106001589 , 2209002761 , 2209002730 , 2209002674 , 2111000113 , 2111000111 , 2208001113
Reason for Recall
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Distribution
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-30
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Medical Division of Stryker Corporation has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Medical Division of Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Medical Division of Stryker Corporation have FDA actions?
Stryker Medical Division of Stryker Corporation has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0435-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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