# FDA recall Z-2496-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2018-05-21.

## Product

Ingenuity Digital PET/CT System, Model 882446 with the following UDI's:   (01)00884838059559(21)900004  (01)00884838059559(21)900005  (01)00884838059559(21)900006  (01)00884838059559(21)900007  (01)00884838059559(21)900008  (01)00884838059559(21)900009  (01)00884838059559(21)900010  (01)00884838059559(21)900011  (01)00884838059559(21)900012  (01)00884838059559(21)900013  (01)00884838059559(21)900014  (01)00884838059559(21)900015  (01)00884838059559(21)900016  (01)00884838059559(21)900017  (01)00884838059559(21)900018  (01)00884838059559(21)900019  (01)00884838059559(21)900020  (01)00884838059559(21)900021  (01)00884838059559(21)900022  (01)00884838059559(21)900023  (01)00884838059559(21)900024  (01)00884838059559(21)900025  (01)00884838059559(21)900026  (01)00884838059559(21)900027  (01)00884838059559(21)900028  (01)00884838059559(21)900029  (01)00884838059559(21)900030  (01)00884838059559(21)900031  (01)00884838059559(21)900032  (01)00884838059559(21)900033  (01)00884838059559(21)9000

## Reason for recall

The block used to connect the patient pallet to the couch may be assembled incorrectly.  A screw may be misaligned in the patient pallet.

## Distribution

Worldwide Distribution - US Nationwide in the states of CA, GA, LA, MD, MI, NY, OH, TN, TX, VT, Washington DC & WI  Internationally - Canada, Mexico, Belgium, France, Israel, Luxembourg, Netherlands, Singapore, Spain & Switzerland

## Key facts

- **Recall number:** Z-2496-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-21
- **Report date:** 2018-07-25
- **Termination date:** 2020-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cleveland, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2496-2018

## Citation

> AI Analytics. FDA recall Z-2496-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2496-2018. Source: US FDA. Licensed CC0.

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